Pharma Regulatory Affairs

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Pharma Regulatory Affairs

  1. 1. INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS (12 MONTHS DISTANCE PARTICIPATION PROGRAM) BATCH- VIIth Offered by: Bioinformatics Institute Of India
  2. 2. WHAT IS PHARMA REGULATORY AFFAIRS (DISTANCE LEARNING PROGRAM) ALL ABOUT ? This Distance learning program is intended to provide students with a basic understanding of the areas of regulatory affairs and quality operations. Students will be prepared for occupations involving drug or medical device submissions and quality assurance functions and roles. The Distance Learning Program will provide the student with the fundamentals required in both regulatory affairs and quality operations.. Experience gained will allow the student to be exposed to one of the many employment possibilities attainable upon graduation . The Distance Learning Program further provides more detailed and specific exposure to the areas of regulatory affairs and quality operation INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
  3. 3. HOW DOES REGULATORY AFFAIRS CERTIFICATION ENHANCES SOMEONE’S EMPLOYMENT PROSPECTS? “ Certified professionals "earn anywhere from 20 to 30% more than their peers. In addition, many companies—both large and small to midsize--are now beginning to indicate that REGULATORY AFFAIRS CERTIFICATION is a desirable qualification." INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
  4. 4. CAREERS IN PHARMA REGULATORY AFFAIRS ? Graduates from this Distance Learning program may pursue careers in the areas of Regulatory Affairs and Quality Operations. Career options include the pharmaceutical, biotechnological, veterinary, cosmetic and food industries. Graduates will find employment as Regulatory Affairs Associates Regulatory Affairs Assistants Quality Assurance Associates Quality Assurance Investigators Documentation Administrators and Medical Information Associates In Contract Research Organization(CRO) Pharma regulatory affairs professionals are responsible for maintaining records of Common Technical Documents for Pharmaceutical Dossiers. INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
  5. 5. HOW MEAN BASE SALARY OF A PHARMA REGULATORY AFFAIRS PROFESSIONAL DIFFER BY EMPLOYER TYPE ? INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS SOURCE: Regulatory Affairs Professional Society
  6. 6. JOBS OPPORTUNITIES AND ROLES FOR PHARMA REGULATORY AFFAIRS PROFESSIONALS ? Regulatory affairs jobs play an important role in the pharmaceutical industry.The pharmaceutical industry has built up rigorous processes for the licensing and compliance of the drugs it uses. Hence Regulatory affairs jobs within pharmaceuticals centres around coordinating and managing licensing processes for everything from the approval of new Medicines, chemicals, medical devices and other products used in pharmaceuticals and healthcare.Once established in regulatory affairs jobs there is are good career structures available which can be pursued within companies, and in addition the pharmaceutical industry is a large pond within which careers can be pursued cross company if necessary . INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
  7. 7. COURSEWARE OFFERED BY BII BOOKS INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
  8. 8. MULTIMEDIA CDs INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
  9. 9. PROGRAM METHODOLOGY INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
  10. 10. REPRESENTATIVE LIST OF OUR CURRENT AND FORMER STUDENTS WHO ARE SUCCESFULLY PLACED AND PRESENTLY WORKING WITH THE LEADING NAMES IN THE PHARMACEUTICAL INDUSTRY
  11. 12. . REPRESENTATIVE LIST OF OUR CURRENT AND FORMER PHARMA REGULATORY AFFAIRS PROGRAM STUDENTS WHO ARE SUCCESFULLY PLACED AND CURRENTLY WORKING WITH THE LEADING NAMES INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS - Regulatory Affairs Executive Micro Labs Ltd. Sangita Poddar . 10 Regulatory Officer IPCA Laboratories Ltd. Lily D'Souza 9 Sr.Officer Reg. Affairs IPCA Laboratories Ltd. Abhay Kenjale 8 Regulatory Affairs Ipca Labs. Ltd. Dipeeka Satve 7 Regulatory Affairs -Executive Bal Pharma Ltd. Bharathi B.K. Burli 6 Executive-Regulatory Affairs Pavucoa Biotech Ltd. Pankaj Bhatt 5 Manager- Regulatory Affairs Associated Capsules Pvt.Ltd. Viren Doke 4 Regulatory Officer Calix Chemicals & Pharmaceuticals Pvt.Ltd. Visalia Abhijit Mali 3 GM - egulatory Affairs Erica Pharma Pvt. Ltd. Shilpa Arun Pitale 2 Regulatory Affairs Techno Drugs Alpa Sameer Gandhi 1 Designation and Department Company Name S.no
  12. 13. INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS Executive Regulatory affairs Medriech Sterilab Ltd. Shaker Gopala Krishna 23 Executive -Reg.Affairs Indoco Remedies Ltd. Visalia Premed Chaudhary 22 Executive - Regulatory Affairs Micro Labs Garcia V. 21 Manager Compliance & Regulatory Fresenius Kabi India Pvt. Ltd. Arun Digamber Kulkarni 20 Regulatory Officer Cipla Ltd Sweat Shaker Baing 19 Executive Regulatory affairs Cipla Ltd. Mangesh Karbhari Sahane 18 Executive Regulatory affairs Aristo Pharma Christancia Celina D'Souza 17 Officer- Regulatory Affairs Medreich Ltd. N. Sridhar 16 Executive Regulatory affairs IPCA Laboratories Ltd. Akhlas Ahmed 15 Supervisor Regulatory Affairs Medreich Ltd. Manjunath R. 14 Regulatories Affairs Medreich Ltd. Sowmya Shree R. 13 Trainee Regulatory Affairs Ajanta Pharma Ltd. Johnson & JohnsonLtd. Anita Murali 12 Officer-Drug regulatory Affairs Ajanta Pharma Ltd. Mrs. Mrunal Sameer Gokhale 11
  13. 14. INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS Chemist Reg.Affairs Phlox Pharma Ltd HardayalSingh Dhanjal 34 Chemist Reg.Affairs Alembic Ltd. SandeepSingh 33 Regulatory affairs-Executive Strides Arcolab Ltd Anitha K.N. 32 Trainee in Regulatory Affairs Wockhardt Ltd. Sujata Suresh Dali 31 Reg.Officer Cipla Ltd. Deepali Ashish Kulkarni 30 Regulatory Work Yamsi Lab Ltd Solapur Midc Area Adam Govardhan Shrinivas 29 Regulatory Manager Forum Products Sachin Rawal 28 Officer- Regulatory Affairs Glochem Industries Ltd. Venkata Rajesh Dasyapu 27 Officer-Regulatory Affairs Marck Biosciences Ltd. Jingoish Rohit kumar 26 Regulatory Affairs-Officer Galaxosmithk Line Sneak Susan Abraham 25 Regulatory Affairs-Officer SRS Pharma Rashmi Danker 24
  14. 15. INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS Tech. Executive-Regulatory Affairs Sales Worth India Ltd. Ramesh Pennama Reddy 47 Trainee-Regulatory Affairs Goldstein Laboratories, Chennai Geetha Priya 46 Manager-Regulatory Affairs Themis Medicare Ltd. Sukh Nandan Singh 45 Executive-Regulatory Affairs Inno Pharm Pvt Ltd. M. Reeta 44 Manager-Regulatory Affairs Orchid Chem & Pharma Jasbinder Singh 43 Associate-Regulatory Affairs Jubiliant Organosys, Noida Ruchi Jain 42 Executive-Regulatory Affairs Cosme Health Care Amrita Sunil Mukherjee 41 Associate-Regulaory Affairs Glenmark Research centre Merilin Lobo 40 Trainee-Regulatory Affairs Aventis Pharma Ltd. Pradnya Vasant Prabhudesai 39 Manager-Regulatory Affairs Redkar Pharma Base India Umaji Bhalchandra 38 Regulatory Head TTK Pharma Ltd. Seettha Ganeshan 37 Trainee –Regulatory Affairs Medopharm S.R. Obliraj 36 Apprentice Trainee-Regulatory Affairs Elder Projects. Shamsundar Pradiprao Nalawade 35
  15. 16. INDUSTRY PROGRAM IN PHARMA REGUALTORY AFFAIRS Sr.Executive-Regulatory Affairs Mankind Pharma Ltd. Delhi Sumit Nagpal 56 Head –Regulatory Affairs Wallace Pharma, Goa Anil Kumar 55 Officer -Regulatory Affairs Indian Immuno Logicals Ltd. N.M. Vijaya Lakshmi 54 Trainee-Regulatory Affairs Srushti Pharma Aruna S. 53 Executive-Regulatory Affairs Strides Arcolab Mohammed Shakeel S. 52 Officer-Regulatory Affairs Suven Life Sciences Ltd Gosika Narendra 51 Officer-Regualtory Affairs Ranbaxy Laboratory Ltd. Sanjeev Mahajan 50 Tr.Officer-Regulatory Affairs Lupin Ltd. Roopa Shiv Kumar Bansal 49 Asst.-Regulatory Affairs Axis Diagnostics & Biotech Ltd. Shraddha Srivastava 48
  16. 17. INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS Trainee-Regulatory Affairs Subriya Pharmaceuticals Ltd. Sudhir Kumar Sharma 66 Apprentice-Regulatory Affairs Meyer Organics Pvt.Ltd. Meenal Yeole 65 Regulatory Affairs Ranbaxy Research Lab Susheel Agarwal 64 Executives-Regulatory Affairs Plethico Pharmaceuticals Sharada Bhaskar Mayekar 63 Officer-Regulatory Affairs Maneesh Pharma. Pvt.Ltd. Mumbai Sujata Tukaram walke 62 Manager-Regulatory Affairs Wockhardt Ltd. Sunil Pal 61 Trainee-Regulatory Affairs Vestergaaxd Erandson Rashmi Dawar 60 Sr.Executive-Regulatory Affairs Nicholas Piramal Ltd. Cipla , Goa Swanand S. Kelkar Samar Gadam 59 Executive-Reglaory Affairs Deccan Neutra Ceutical Pvt.Ltd. Nidhi Jain 58 Executive-Regulatory Affairs Ranbaxy Lab.Ltd Harjit Singh 57
  17. 18. INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS Regulatory Officer Emcure Pharma Balchandra Ghare 76 Sr.Executives-Regulatory Affairs M/s.Bioserve Chemical Research Pvt.Ltd. Ulligadla Anjan Kumar 75 Senior Executive Regulatory Affairs Dr.Reddy,s Laboratory N. Rajan 74 Trainee-Regulatory Affairs Cipla Ltd. Vijay Sah Sarita Chaudhary 73 Executive-Regulatory Affairs Elder Pharmaceuticals Shital Kumar Takale 72 Regulatory Head Morepen Labs ltd. Arun Kumar 71 Junior Regulatory Officer German Remedies Ltd. Rashmi Pillay 70 Sr.Regulatory Officer Banglore Pharmaceuticals & Research Ltd. Dilip Kumar Saralaya 69 Trainee-Regulatory Affairs Alpha Beta Pvt.Ltd. Siddhartha Roy 68 Sr.Executive-Regulatory Affairs Merind Ltd, India Premjith Balakrishnan 67
  18. 19. INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS Executive Regulaory Affairs Strides Arcolab Indrajit Bhosle Patil 82 Trianee-Regulatory Affairs Ranbaxy Pradeep Srivastava 81 Sr.Officer-Regulatory Ind.Swift Laboratories Ltd. Rajni Chaudhary 80 Sr.Officer-Regulatory Windlas Biotech Ltd. Girija Shankar Tiwari 79 Head –Regulatory Affairs Meyer Health Care Pvt.Ltd., Banglore Sree Lakshmi Konakanchi 78 Sr Executive Regulatory Affairs Dr. Reddy,s Lab Sachin Shiral 77
  19. 20. INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS Executives – Regulatory Affairs Nicholas Piramal. Swanand S. Kelkar 86 Officer-Regulatory Indian Immuno Logicals Ltd. N.M. Vijaya Lakshmi 85 Regulaory Head Srushti Pharma Aruna S. 84 Regulaory Officer Suven Life Sciences Ltd. Gosika Narendra 83 Manager-Regulatory Affairs Glenmark Pharma Ltd. Amit Bhardwaj 91 Regulatory Department Aurobindo pharma Ltd. Anupama Moorthigari 90 GM – Regulatory Operation Proventus Life Sciences Pvt.Ltd. K. Jegadheesh Balaji 89 Executive-Regulatory Affairs Virchow Biotech Pvt.Ltd. Ravi Kumar Uddanti 88 Sr.Executive –Regulatory Affairs Wockhard Sunil Pal 87
  20. 21. INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS Officer-Regulatory Affairs Aurobindo Pharma Ltd. Pothineni Prashanthi 96 Head-Regulatory Affairs Glaxo Smithkline Pvt. Ltd. Rafik Patil 95 Trainee-Regulatory Affairs Lupin Ltd. Devleena Sengupta 94 Officer-Regulatory Affairs Sandoz Pvt. Ltd. Nitin Patil 93 Head-Regulatory Affairs Sandoz Pvt. Ltd. Jayant Khuspe 92
  21. 22. HOW TO JOIN THE DISTANCE PARTICIATION PROGRAM IN PHARMA REGULATORY AFFAIRS ? In order to join BII Industry Program in Pharma Regulatory Affairs the prospective participants has to submit the necessary form and the same can be downloaded from www.Bii.in <ul><li>Eligibility The eligibilty for the training program is graduation in any discipline.Highly interested participants in final year can also apply. </li></ul><ul><li>Program Fee BII Program Participation Fee for this program is Rs 10300 (for participants based in India / USD 750 ( for overseas participants ). Payment is to be made through Demand Draft / Telegraphic Transfer in favor of Bioinformatics Institute of India Payable at Noida/Delhi </li></ul><ul><li>Examination Fees Every student has to pay Rs.200/- per module as examination fees . Examination fee for overseas participants is USD 25 Per Module </li></ul>INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
  22. 23. THANK YOU <ul><li>For Further Details And Enquiries Contact </li></ul><ul><li>Bioinformatics Institute Of India </li></ul><ul><li>C-56A/28, Sector-62 </li></ul><ul><li>Noida-2010301, U.P. </li></ul><ul><li>Tel:0120-4320801/02 Mobile:9818473366 , 9810535368 </li></ul><ul><li>Email: [email_address] </li></ul><ul><li>Visit: www.bii.in </li></ul>

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