Tushar Gadge has over 5 years of experience in regulatory affairs. He has worked as a team leader for Ajanta Pharma and Bliss GVS Pharma, preparing dossiers for registration in various countries. He is experienced in dossier preparation for CTD, EU-CTD, African-CTD formats. Previously he worked for Cipla as a regulatory affairs professional, preparing dossiers for Central and South America. He has skills in handling queries, reviewing data, and ensuring compliance. He seeks to contribute his skills and experience to an organization providing opportunities for growth.
Fadi Al Milli is a regulatory affairs, tender, and quality manager based in Amman, Jordan with over 10 years of experience. He oversees the product registration process for government approval and handles interactions with health authorities. Fadi has extensive experience leading creative teams and developing marketing campaigns. He has skills in regulatory compliance, product development, and relationship management.
Justice Ronald was born in Oman in 1967 and holds Pakistani nationality. He has over 25 years of experience in sales roles within the healthcare industry in Pakistan. His objective is to obtain a challenging position in a dynamic healthcare company where he can offer medical solutions to hospitals and universities to improve patient care. He has a bachelor's degree in science from Karachi University and extensive knowledge of various medical equipment.
Zaina Anwar is a certified pharmacy graduate seeking a position that allows her to utilize her regulatory affairs experience. She has over 3 years of experience working with pharmaceutical companies on product registrations, renewals, and variations with health authorities in the UAE and GCC region. Her experience also includes pharmacovigilance, clinical research, and marketing. She is proficient in English and Arabic and has a Bachelor's degree in Pharmacy from the University of Sharjah.
Priyank Srivastava is a regulatory affairs professional seeking a management position. He has over 7 years of experience in regulatory affairs and quality assurance. Currently he works as a regulatory affairs specialist at Accredited Consultants Private Ltd., where he is responsible for ensuring regulatory compliance and managing product registrations. Previously he worked as Quality Assurance and Quality Control Head at Real Chemsys Products, where he implemented quality systems and oversaw quality control testing. He has expertise in medical devices, drugs, biologicals, and nutraceuticals regulatory requirements in India and other markets.
Sravan Bandi seeks a role in regulatory affairs where he can utilize his 3 years of experience with US FDA, Brazil ANVISA, and China CFDA regulations. He currently works as a Research Associate at Aurobindo Pharma overseeing regulatory submissions and communications for the US, Brazil, and China. Key responsibilities include compiling drug dossiers, responding to agency requests, and ensuring technical documents comply with various regulations. Previously, Sravan worked as a chemistry lecturer and holds an MPharm and BPharm with specializations in pharmaceutics.
Talal Ahmed Siddiqui is seeking new opportunities as an audit senior with over 5 years of experience. He has worked at SMSC and Muhammad Farooq & Co., conducting external and internal audits, advisory services, accounting assignments, and quality control reviews. His experience includes audit documentation, verification of inventories and cash, analytical reviews, and preparation of financial statements and audit reports. He has a bachelor's degree in commerce and is pursuing the CMA certification.
EirGen Pharma, based in Waterford, Ireland, is currently recruiting for quality control chemists, analytical development chemists, regulatory affairs officers, and QA officers. EirGen is the supply chain and R&D center of excellence for OPKO Health, exporting medicines to over 45 countries worldwide. The company employs over 170 people from 9 nationalities and offers a competitive benefits package.
EirGen Pharma, based in Waterford, Ireland, is currently recruiting for quality control chemists, analytical development chemists, regulatory affairs officers, and QA officers. EirGen is the supply chain and R&D center of excellence for OPKO Health, exporting medicines to over 45 countries worldwide. The company employs over 170 people from 9 nationalities and offers a competitive benefits package.
Fadi Al Milli is a regulatory affairs, tender, and quality manager based in Amman, Jordan with over 10 years of experience. He oversees the product registration process for government approval and handles interactions with health authorities. Fadi has extensive experience leading creative teams and developing marketing campaigns. He has skills in regulatory compliance, product development, and relationship management.
Justice Ronald was born in Oman in 1967 and holds Pakistani nationality. He has over 25 years of experience in sales roles within the healthcare industry in Pakistan. His objective is to obtain a challenging position in a dynamic healthcare company where he can offer medical solutions to hospitals and universities to improve patient care. He has a bachelor's degree in science from Karachi University and extensive knowledge of various medical equipment.
Zaina Anwar is a certified pharmacy graduate seeking a position that allows her to utilize her regulatory affairs experience. She has over 3 years of experience working with pharmaceutical companies on product registrations, renewals, and variations with health authorities in the UAE and GCC region. Her experience also includes pharmacovigilance, clinical research, and marketing. She is proficient in English and Arabic and has a Bachelor's degree in Pharmacy from the University of Sharjah.
Priyank Srivastava is a regulatory affairs professional seeking a management position. He has over 7 years of experience in regulatory affairs and quality assurance. Currently he works as a regulatory affairs specialist at Accredited Consultants Private Ltd., where he is responsible for ensuring regulatory compliance and managing product registrations. Previously he worked as Quality Assurance and Quality Control Head at Real Chemsys Products, where he implemented quality systems and oversaw quality control testing. He has expertise in medical devices, drugs, biologicals, and nutraceuticals regulatory requirements in India and other markets.
Sravan Bandi seeks a role in regulatory affairs where he can utilize his 3 years of experience with US FDA, Brazil ANVISA, and China CFDA regulations. He currently works as a Research Associate at Aurobindo Pharma overseeing regulatory submissions and communications for the US, Brazil, and China. Key responsibilities include compiling drug dossiers, responding to agency requests, and ensuring technical documents comply with various regulations. Previously, Sravan worked as a chemistry lecturer and holds an MPharm and BPharm with specializations in pharmaceutics.
Talal Ahmed Siddiqui is seeking new opportunities as an audit senior with over 5 years of experience. He has worked at SMSC and Muhammad Farooq & Co., conducting external and internal audits, advisory services, accounting assignments, and quality control reviews. His experience includes audit documentation, verification of inventories and cash, analytical reviews, and preparation of financial statements and audit reports. He has a bachelor's degree in commerce and is pursuing the CMA certification.
EirGen Pharma, based in Waterford, Ireland, is currently recruiting for quality control chemists, analytical development chemists, regulatory affairs officers, and QA officers. EirGen is the supply chain and R&D center of excellence for OPKO Health, exporting medicines to over 45 countries worldwide. The company employs over 170 people from 9 nationalities and offers a competitive benefits package.
EirGen Pharma, based in Waterford, Ireland, is currently recruiting for quality control chemists, analytical development chemists, regulatory affairs officers, and QA officers. EirGen is the supply chain and R&D center of excellence for OPKO Health, exporting medicines to over 45 countries worldwide. The company employs over 170 people from 9 nationalities and offers a competitive benefits package.
Saurabh Agrawal is seeking an opportunity in regulatory affairs. He has over 3 years of experience in regulatory affairs consulting and as a regulatory executive. His experience includes new drug approvals, medical device and drug registrations, import/export licenses, and compiling drug dossiers for international markets like Myanmar, Cambodia, and others. He has a M.Pharm degree and B.Pharm degree and is computer proficient in Microsoft Office programs.
Sravan Bandi is a regulatory affairs professional with over 4 years of experience in US FDA and Brazil ANVISA regulations. He has a Master's degree in Pharmacy and is currently working as a Regulatory Affairs Research Associate IV at Aurobindo Pharma Limited. His responsibilities include ANDA compilation and submissions, responding to queries, and preparing post-approval documents for the US, Brazil, China, and other markets. He has strong technical skills in dossier preparation and a thorough knowledge of pharmaceutical development documentation requirements.
K. Sailaja has over 8 years of experience in regulatory affairs. She holds an M.Pharmacy degree and has worked for several pharmaceutical companies in regulatory roles, including Manager of Regulatory Affairs at Micro-Therapeutic Research Labs and Associate Manager of Regulatory Affairs at Novartis Animal Health. Her responsibilities have included filing applications, ensuring compliance, coordinating with other departments, and preparing and reviewing documents. She is proficient in MS Office, has attended training programs in communication and presentation skills, and aims to work in a challenging position that allows her to utilize her skills and experience.
K. Sailaja has over 8 years of experience in regulatory affairs. She holds an M.Pharmacy degree and has worked for several pharmaceutical companies in regulatory roles, including Manager of Regulatory Affairs at Micro-Therapeutic Research Labs and Associate Manager of Regulatory Affairs at Novartis Animal Health. Her responsibilities have included filing applications, ensuring compliance, coordinating with other departments, and preparing and reviewing documents. She is proficient in MS Office, has attended training programs in communication and presentation skills, and aims to work in a challenging position that allows her to utilize her skills and experience.
The document is a cover letter and resume from Deepthi Kondapalli applying for a position in regulatory affairs. She has over 5 years of experience in regulatory affairs and quality assurance at Aurobindo Pharma Limited. Her experience includes international submissions, audits, variation procedures, and ensuring documentation compliance. She is seeking the position due to the company's leadership, culture of innovation, and challenges of international audits.
Hitesh Patel has over 3 years of experience in the pharmaceutical industry working in quality assurance and quality control roles. He holds a Master's degree in Pharmaceutical Science from the University of Greenwich in the UK and a Bachelor's degree in Pharmacy. Currently he works as a Senior Quality Assurance Officer at Famycare Ltd in Ahmedabad, India where he is involved in validation activities, documentation review, and audits. Previously he worked at Nirlife Healthcare as a Quality Assurance Officer where his responsibilities included batch record review, deviation handling, and pre-dispatch inspections.
Saravanan is seeking a challenging position in quality assurance and regulatory affairs with his 7 years of experience in the pharmaceutical industry. He has expertise in validation activities including process, cleaning, and equipment qualification. His responsibilities have included handling cleaning and process validation protocols and batches, coordinating audits, issuing and archiving batch documents, and preparing quality review reports. He is proficient in computer systems and has experience working with regulatory agencies from various countries.
Sanket Kumar Patra is seeking a new opportunity in quality management. He has over 10 years of experience in quality assurance and has expertise in auditing, investigating complaints and deviations, managing corrective and preventative actions, and ensuring regulatory compliance. He is a certified GreenBelt in quality management and holds an MBA and Master's degree in quality management.
Prushin Mananbhai Thakore is seeking a position that allows him to help an organization grow while further developing his own skills and knowledge. He has over 2.7 years of experience working in regulatory affairs at Claris Injectables Limited. His responsibilities include preparing and maintaining regulatory documentation for product submissions and registrations in various countries, communicating with partners, and reviewing technical documents to ensure compliance. Prushin holds an M.Pharm in Pharmacology with 2 years of relevant work experience and is interested in continuing his career in regulatory affairs.
Pharmaceutical qualification and validations trainingMarcep Inc.
INTRODUCTION
This summit outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacturing of any pharmaceutical product, including APIs or drug item, referred to in this training summit as drugs. This training summit incorporates principles and approaches that all pharmaceutical manufacturers can use to validate manufacturing processes in their respective organizations
after attending the course.
This resume summarizes Amit Patel's educational qualifications and professional experience in regulatory affairs and quality assurance. He has a Master's degree in Pharmacy from Jaipur National University and has over 5 years of experience preparing drug dossiers and responding to regulatory queries for companies in India and Africa. His current role involves dossier preparation for markets like South Africa, Kenya, Nigeria and preparing responses to regulatory authorities.
Waseem Mohammed is a regulatory affairs and quality management professional with over 4 years of experience in the pharmaceutical industry. He has a Master's degree from the University of Greenwich and a Bachelor's degree from Osmania University. His experience includes roles managing quality assurance and serving as a quality coordinator at NSF Pharma PVT Ltd in India. He also has experience in customer service management at Sainsbury Plc in the UK and conducting market research and business analysis for a traffic data center in the UK.
Waseem Mohammed is a clinical research associate with over 2 years of experience in quality management and clinical trials. He has strong knowledge of ICH-GCP guidelines, clinical trial design, data management, and safety reporting. His past roles include quality assurance coordinator for NSF Pharma and customer service management for Sainsbury Plc in the UK. Waseem holds an advanced postgraduate diploma in clinical trials and pharmacovigilance from Medwin Hospital along with a bachelor's degree in pharmacy from Osmania University. He is seeking a new role as a CRA or clinical SAS programmer.
Gaurav Soni is seeking a position in regulatory affairs with 7 years of experience in pharmaceutical quality assurance and regulatory roles. He currently works as a Senior Research Associate at Intas Pharmaceuticals assisting with batch releases in European countries. Previously he worked at Lupin Limited and Glaxosmithkline Pharmaceuticals. He has experience with dossier preparation, variation submissions, audits, and ensuring compliance with regulations in countries like the US, UK, and Europe. Gaurav holds an M.Pharm degree and provides his resume and details of his qualifications and responsibilities in previous roles.
P. Murthy Raju is a Production Officer with over 8 years of experience in the pharmaceutical industry. He is looking for a challenging position in manufacturing that allows him to grow professionally. He has a MSc in Chemistry and has worked at Mylan Laboratories and Divis Laboratories. Some of his responsibilities include production planning, supervision, achieving targets, ensuring quality, technology transfer, process improvements, audits, and safety training. He has knowledge of SAP, process validation, cGMP guidelines, troubleshooting, and change control. He aims to contribute to organizational goals through his technical and communication skills.
CELUI Services provides consulting services related to the pharmaceutical industry, including regulatory affairs, pharmacovigilance, global liaison, contract manufacturing, patent and trademark registration, translation, and technology transfer. The company has a team of experienced professionals who previously worked for major Indian pharmaceutical companies. CELUI Services aims to provide quality, customized services to clients in a cost-effective manner. The document provides details on the various services offered.
Hitesh Patel has over 5 years of experience in the pharmaceutical industry working in quality assurance and quality control roles. He holds a B.Pharm degree from Rajiv Gandhi University of Health Sciences in Bangalore and an M.S. degree from the University of Greenwich in the UK. Currently he works as a Senior Officer in quality assurance at Intas Pharmaceuticals Ltd. He has experience with validation, documentation, complaint handling, and regulatory audits. His professional skills include Microsoft Office, communication, and familiarity with SAP systems.
working in Quality assurance department in Qualification and validation department.
involve in new equipment qualification like multi connected tank ( Skid).
involve in media fill activity and investigation.
involve in qualification of HVAC.
involve in new facility startup activity.
Satish Reddy Mandala is applying for a suitable position in the human resources department. He holds a Master's degree in Pharmacy from SRM University, Chennai. He has over 8 years of experience in quality assurance roles at various pharmaceutical companies, including his current role as Assistant Manager at Dr. Reddy's Laboratories. He is seeking new opportunities to further develop his skills and contribute to an organization.
Anupam patel 03y exp m.pharm (ra) & mba (internation bus)Anupam Patel
With 3years of hand-on, successful pharmaceutical experience in Regulatory Affairs & International Business, I am confident in my ability and passion to become a positive addition to this organization as an Asst. Manager or as per your requirement.
Saurabh Agrawal is seeking an opportunity in regulatory affairs. He has over 3 years of experience in regulatory affairs consulting and as a regulatory executive. His experience includes new drug approvals, medical device and drug registrations, import/export licenses, and compiling drug dossiers for international markets like Myanmar, Cambodia, and others. He has a M.Pharm degree and B.Pharm degree and is computer proficient in Microsoft Office programs.
Sravan Bandi is a regulatory affairs professional with over 4 years of experience in US FDA and Brazil ANVISA regulations. He has a Master's degree in Pharmacy and is currently working as a Regulatory Affairs Research Associate IV at Aurobindo Pharma Limited. His responsibilities include ANDA compilation and submissions, responding to queries, and preparing post-approval documents for the US, Brazil, China, and other markets. He has strong technical skills in dossier preparation and a thorough knowledge of pharmaceutical development documentation requirements.
K. Sailaja has over 8 years of experience in regulatory affairs. She holds an M.Pharmacy degree and has worked for several pharmaceutical companies in regulatory roles, including Manager of Regulatory Affairs at Micro-Therapeutic Research Labs and Associate Manager of Regulatory Affairs at Novartis Animal Health. Her responsibilities have included filing applications, ensuring compliance, coordinating with other departments, and preparing and reviewing documents. She is proficient in MS Office, has attended training programs in communication and presentation skills, and aims to work in a challenging position that allows her to utilize her skills and experience.
K. Sailaja has over 8 years of experience in regulatory affairs. She holds an M.Pharmacy degree and has worked for several pharmaceutical companies in regulatory roles, including Manager of Regulatory Affairs at Micro-Therapeutic Research Labs and Associate Manager of Regulatory Affairs at Novartis Animal Health. Her responsibilities have included filing applications, ensuring compliance, coordinating with other departments, and preparing and reviewing documents. She is proficient in MS Office, has attended training programs in communication and presentation skills, and aims to work in a challenging position that allows her to utilize her skills and experience.
The document is a cover letter and resume from Deepthi Kondapalli applying for a position in regulatory affairs. She has over 5 years of experience in regulatory affairs and quality assurance at Aurobindo Pharma Limited. Her experience includes international submissions, audits, variation procedures, and ensuring documentation compliance. She is seeking the position due to the company's leadership, culture of innovation, and challenges of international audits.
Hitesh Patel has over 3 years of experience in the pharmaceutical industry working in quality assurance and quality control roles. He holds a Master's degree in Pharmaceutical Science from the University of Greenwich in the UK and a Bachelor's degree in Pharmacy. Currently he works as a Senior Quality Assurance Officer at Famycare Ltd in Ahmedabad, India where he is involved in validation activities, documentation review, and audits. Previously he worked at Nirlife Healthcare as a Quality Assurance Officer where his responsibilities included batch record review, deviation handling, and pre-dispatch inspections.
Saravanan is seeking a challenging position in quality assurance and regulatory affairs with his 7 years of experience in the pharmaceutical industry. He has expertise in validation activities including process, cleaning, and equipment qualification. His responsibilities have included handling cleaning and process validation protocols and batches, coordinating audits, issuing and archiving batch documents, and preparing quality review reports. He is proficient in computer systems and has experience working with regulatory agencies from various countries.
Sanket Kumar Patra is seeking a new opportunity in quality management. He has over 10 years of experience in quality assurance and has expertise in auditing, investigating complaints and deviations, managing corrective and preventative actions, and ensuring regulatory compliance. He is a certified GreenBelt in quality management and holds an MBA and Master's degree in quality management.
Prushin Mananbhai Thakore is seeking a position that allows him to help an organization grow while further developing his own skills and knowledge. He has over 2.7 years of experience working in regulatory affairs at Claris Injectables Limited. His responsibilities include preparing and maintaining regulatory documentation for product submissions and registrations in various countries, communicating with partners, and reviewing technical documents to ensure compliance. Prushin holds an M.Pharm in Pharmacology with 2 years of relevant work experience and is interested in continuing his career in regulatory affairs.
Pharmaceutical qualification and validations trainingMarcep Inc.
INTRODUCTION
This summit outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacturing of any pharmaceutical product, including APIs or drug item, referred to in this training summit as drugs. This training summit incorporates principles and approaches that all pharmaceutical manufacturers can use to validate manufacturing processes in their respective organizations
after attending the course.
This resume summarizes Amit Patel's educational qualifications and professional experience in regulatory affairs and quality assurance. He has a Master's degree in Pharmacy from Jaipur National University and has over 5 years of experience preparing drug dossiers and responding to regulatory queries for companies in India and Africa. His current role involves dossier preparation for markets like South Africa, Kenya, Nigeria and preparing responses to regulatory authorities.
Waseem Mohammed is a regulatory affairs and quality management professional with over 4 years of experience in the pharmaceutical industry. He has a Master's degree from the University of Greenwich and a Bachelor's degree from Osmania University. His experience includes roles managing quality assurance and serving as a quality coordinator at NSF Pharma PVT Ltd in India. He also has experience in customer service management at Sainsbury Plc in the UK and conducting market research and business analysis for a traffic data center in the UK.
Waseem Mohammed is a clinical research associate with over 2 years of experience in quality management and clinical trials. He has strong knowledge of ICH-GCP guidelines, clinical trial design, data management, and safety reporting. His past roles include quality assurance coordinator for NSF Pharma and customer service management for Sainsbury Plc in the UK. Waseem holds an advanced postgraduate diploma in clinical trials and pharmacovigilance from Medwin Hospital along with a bachelor's degree in pharmacy from Osmania University. He is seeking a new role as a CRA or clinical SAS programmer.
Gaurav Soni is seeking a position in regulatory affairs with 7 years of experience in pharmaceutical quality assurance and regulatory roles. He currently works as a Senior Research Associate at Intas Pharmaceuticals assisting with batch releases in European countries. Previously he worked at Lupin Limited and Glaxosmithkline Pharmaceuticals. He has experience with dossier preparation, variation submissions, audits, and ensuring compliance with regulations in countries like the US, UK, and Europe. Gaurav holds an M.Pharm degree and provides his resume and details of his qualifications and responsibilities in previous roles.
P. Murthy Raju is a Production Officer with over 8 years of experience in the pharmaceutical industry. He is looking for a challenging position in manufacturing that allows him to grow professionally. He has a MSc in Chemistry and has worked at Mylan Laboratories and Divis Laboratories. Some of his responsibilities include production planning, supervision, achieving targets, ensuring quality, technology transfer, process improvements, audits, and safety training. He has knowledge of SAP, process validation, cGMP guidelines, troubleshooting, and change control. He aims to contribute to organizational goals through his technical and communication skills.
CELUI Services provides consulting services related to the pharmaceutical industry, including regulatory affairs, pharmacovigilance, global liaison, contract manufacturing, patent and trademark registration, translation, and technology transfer. The company has a team of experienced professionals who previously worked for major Indian pharmaceutical companies. CELUI Services aims to provide quality, customized services to clients in a cost-effective manner. The document provides details on the various services offered.
Hitesh Patel has over 5 years of experience in the pharmaceutical industry working in quality assurance and quality control roles. He holds a B.Pharm degree from Rajiv Gandhi University of Health Sciences in Bangalore and an M.S. degree from the University of Greenwich in the UK. Currently he works as a Senior Officer in quality assurance at Intas Pharmaceuticals Ltd. He has experience with validation, documentation, complaint handling, and regulatory audits. His professional skills include Microsoft Office, communication, and familiarity with SAP systems.
working in Quality assurance department in Qualification and validation department.
involve in new equipment qualification like multi connected tank ( Skid).
involve in media fill activity and investigation.
involve in qualification of HVAC.
involve in new facility startup activity.
Satish Reddy Mandala is applying for a suitable position in the human resources department. He holds a Master's degree in Pharmacy from SRM University, Chennai. He has over 8 years of experience in quality assurance roles at various pharmaceutical companies, including his current role as Assistant Manager at Dr. Reddy's Laboratories. He is seeking new opportunities to further develop his skills and contribute to an organization.
Anupam patel 03y exp m.pharm (ra) & mba (internation bus)Anupam Patel
With 3years of hand-on, successful pharmaceutical experience in Regulatory Affairs & International Business, I am confident in my ability and passion to become a positive addition to this organization as an Asst. Manager or as per your requirement.
Anupam patel 03y exp m.pharm (ra) & mba (internation bus)
TUSHAR RESUME NEW
1. Tushar P. Gadge
RESUME
Objective
To seek a career in an organization, which provides an environment contributing to continuous
learning and provides exposure to new and innovative ideas, where my skills would be utilized
to the fullest potential, thereby achieving personal and professional growth.
Summary
I am Tushar Gadge (B. Pharmacy – MBA Pharmaceuticals) having more than 5 years experience
in Regulatory Affairs. I am well versed with the registration requirements of Latin America,
Africa, CIS countries, Middle East, Asian countries, South East Asian countries and requirements
of EMA.
Work Experience
CURRENT EMPLOYER:
AJANTA PHARMA LIMITED (8st
Dec 2014 to till now)
Company Profile: Manufacturer of Pharmaceutical Products.
Position: Team Leader
Job Profile:
- Preparation of Technical Dossiers in CTD, African-CTD, A-CTD & Non-CTD format for CIS
countries, Africa, Asia, Latin America & ROW countries.
- To check & review dossier prepared by Team
- Assure completeness and overall content of the submissions
- To check data received from QA/QC/RND
- To handle queries raised by regulatory authority
- Registration, Re-registration & to take approvals periodically
- Data review for master dossiers
- Master dossier uploads in ERP system
- Master dossier publishing
- Master dossier extraction from master ERP
LAST EMPLOYER:
BLISS GVS PHARMA LIMITED (1st
Aug 2012 to 7th
Dec 2014)
Company Profile: Manufacturer of Pharmaceutical Products.
Position: Team Leader
Job Profile:
- Preparation of Technical Dossiers in CTD, EU-CTD, African-CTD, A-CTD & Non-CTD format for
Europe, CIS countries, Africa, Asia, Latin America & ROW countries.
- To check & review dossier prepared by Team
Tushar P. Gadge,
Sumati Niwas, Tirandaz Village, IIT Main Gate, Powai, Mumbai-400076
Eamil- tushargadge@rediffmail.com; tushargadage@gmail.com
Contact Numbers:- 8424059226/9096832196
2. Tushar P. Gadge
- Assure completeness and overall content of the submissions.
- To check data received from QA/QC/RND
- To handle queries raised by regulatory authority.
- Registration, Re-registration & to take approvals periodically.
- To provide the updated information and technical documents in timely manner and try to avoid
the delay in getting of approvals.
- To arrange & provide documents for various tenders.
- To co-ordinate with various departments
PREVIOUS EMPLOYER:
CIPLA LIMITED (March 2010 to 1st
Aug. 2012)
Company Profile: Manufacturer of Pharmaceutical Products.
Position: PRC- Regulatory Affairs
Job Profile:
- Preparation of Technical Dossiers in CTD & Non-CTD format for Central America & South
America.
- To arrange the all requirements for registration & re-registration as per regulatory requirements
& to assure completeness and overall content of the submissions
- Registration, Re-registration & to take approvals periodically
- Site transfer
- Multiple site registration
- To Providing the updated information and technical documents in timely manner and try to
avoid the delay in getting of approvals
- To co-ordinate with various departments
- To handle queries raised by parties & authority
- To arrange & provide documents for various tenders
- To check & approve Change Controls Form for Finished Product, Drug Substance & inactive
agents
- To arrange data from different locations
- To check orders, CMCL, SPMS, Artworks as per registration documents
- To Apply the Certificates of Pharmaceutical Products, Free Sale Certificates, Export Certificates,
Export Certificates / Free Sale Certificates, Local license copy, Export license copy as per
registration requirements
- To provide regulatory support for various departments, projects, and teams
Key Skills
- Knowledge of EMEA submission processes & dossier compilation
Tushar P. Gadge,
Sumati Niwas, Tirandaz Village, IIT Main Gate, Powai, Mumbai-400076
Eamil- tushargadge@rediffmail.com; tushargadage@gmail.com
Contact Numbers:- 8424059226/9096832196
3. Tushar P. Gadge
- Knowledge of Types of Variations
- Knowledge of preparation of dossier in all formats ICH-CTD, EU-CTD, A-CTD, and Non-CTD
- Handling queries regarding product registration
- Data review - for Quality Modules
- To check artworks for packing materials
- To check SPMS
- To fill & check order copies & order documents against registered documents
Additional Skills
- Good communication skill
- Quick learner
- High motivation for self-training on regulatory related frame
- Ability to create and maintain strong and trustful relationship with corporate groups
Achievements
1. Second prize at National Level Poster Presentation organized at MIP College Pune on NDDS
Presentation
- R-DNA Technology (Biotechnology / Microbiology)
- Packing Materials for Parenteral Products & Packing Materials specification (Pharmaceutics)
- Probiotic & Prebiotic (Pharmaceutics)
- Pharmacokinetic & Pharmacodynamics (Pharmacology)
- ADR (Pharmacology)
- Ophthalmic Formulations (Pharmaceutics)
- Drugs Interactions (Pharmacology)
- Small Volume & Large Volume parenteral Preparations (Pharmaceutics)
Academic Qualifications
EXAMINATION UNIVERSITY YEAR
MARKS
(%)
Tushar P. Gadge,
Sumati Niwas, Tirandaz Village, IIT Main Gate, Powai, Mumbai-400076
Eamil- tushargadge@rediffmail.com; tushargadage@gmail.com
Contact Numbers:- 8424059226/9096832196
4. Tushar P. Gadge
MBA Pharmaceuticals
Ulyanovsk Russian State
University
2012-2013 75.00
B. Pharm. Pune University. May 2009 65.08
H. S. C Divisional Board, Maharashtra March 2005 54.16
S. S. C Divisional Board, Maharashtra March 2003 70.66
Basic Knowledge of Windows XP, Microsoft Office 2003, 2007, 2010, Windows 7, Windows 8
Personal Details
Father Name : Mr. Patilbuwa K. Gadge.
Mother Name : Mrs. Suman P. Gadge
Date of Birth : 8th
Sep. 1987
Nationality : Indian
Marital Status : Married
Languages Know : English, Marathi and Hindi.
Tushar P. Gadge
Date: 02-05-2015
Place: Powai-Mumbai
Tushar P. Gadge,
Sumati Niwas, Tirandaz Village, IIT Main Gate, Powai, Mumbai-400076
Eamil- tushargadge@rediffmail.com; tushargadage@gmail.com
Contact Numbers:- 8424059226/9096832196