The document is a curriculum vitae for Santanu Roy that outlines his career experience and qualifications. Some key points: - Santanu has over 10 years of experience in regulatory affairs and quality assurance roles for pharmaceutical companies in India. - His experience includes preparing regulatory submissions for markets like the US, Asia, Africa and preparing responses to deficiencies. - Currently he works as manager of regulatory affairs at Glenmark Pharmaceuticals where he is responsible for CMC strategies and submissions.

1. CURRICULUM VITAE
SANTANU ROY
Present Address:
Adwalparkar Enclave
Flat B-401
Canca,Mapusa
GoA,India-403507
Mobile No. +91-7722044847
Mail-ID: santanu_2k1@rediffmail.com
Skype-ID: santanu.roy0609
Permanent Address:
S/O.- Late Sunil Gopal Roy
Dayal Complex, Flat No.304A
Radhanagar Road, P.O- Burnpur,
Dist- Burdwan,
Pin- 713325, West Bengal (India)
CAREER OBJECTIVE
Seeking a challenging opportunity in Regulatory Affairs position that will utilize my pharmaceutical
industry knowledge and experience to aid in the life cycle management of existing products and provide
regulatory advice for bringing new products to market.
EXPERIENCE AND SKILLS
 Six months working cum training in Quality Assurance ( Six Sigma and Statistical Process
Control) as a management trainee at Sanofi-Aventis Ltd., Goa, India
 Two years and nine months experience in Quality Assurance, Quality Management System,
CAPA, & Quality Audit Compliance as an Executive at Orchid Health Care Ltd., Chennai, India.
 One year and seven months experience in collection and organization of dossiers for USA-FDA’s
Abbreviated New Drug Application (ANDA) as an Executive at Wockhardt Ltd., Aurangabad,
India.
 One year and seven months experience in preparation and compilation of documents of regulations
and for drug registration processes for USA-FDA’s Abbreviated New Drug Application (ANDA)
as an Asst. Manager at Macleods Ltd., Mumbai, India.
 Two years and six months experience in preparation and compilation of documents of regulations
and for drug registration processes for USA-FDA’s Abbreviated New Drug Application (ANDA)
as an Executive at SUN Pharmaceuticals Industries Ltd., Vadodara, India.
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2.  Ten months experience in preparation and compilation of documents of regulations and for drug
registration processes for emerging markets such as Asia Pacific, Africa, Middle East, Srilanka &
Mongolia at PT. Bernofarm, Surabaya, Indonesia.
 Experience with clinical trial phase of development e.g. IND/CTA requirements.
 Development and preparation of successful regulatory strategies
 Played an active role as a team member of different teams that are formed to update the
Formulation development area, manufacturing area and quality assurance area as per cGMP
requirements.
 Demonstrated analytical and communication skills that encompass identifying critical concepts,
solving complex problems, presenting complex ideas in a clear, concise and persuasive manner
Strong planning, analytical and problem solving skills.
 Proven ability to effectively managing and multiple projects, contribute effectively to project
teams, achieve deadlines and collaborate with colleagues on a global level.
 Coordinated with other departments to ensure smooth transition of projects into commercial
production.
 Ensure specifications for testing of API/drug substance/drug product and documentation of raw
materials (novel excipients, animal derived materials, etc.) comply with regulatory requirements.
 Ensure specifications for device components, manufacturing process, and product have been
defined and meet regulatory requirements.
 Evaluate manufacturing changes for compliance with appropriate change control systems/process
and determine regulatory filing strategy.
 Assess and verify the adequacy of data to support submission approval and desired label
claims/product specifications.
 Assess and verify the readiness of the drug/device manufacturing facility for PAI (Ensure
compliance with GMP and QSR).
CURRENT JOB PROFILE
Working Global Regulatory Affairs & CMC-Compliance at Glenmark Pharmaceutical Ltd., Two Years
as Manager (Since Sept’14 -Till date)
CURRENT JOB RESPONSIBILITY
 Monitoring of project timelines, deliverers and costs for Drug Product.
 The formulation and implementation of global regulatory CMC strategy at the commercial and
development levels.
 The formulation and implementation of regulatory CMC strategy for dermatologic and metabolic
products at the commercial and development levels.
 Assessment of change controls for internationally distributed biopharmaceutical.
 Planned and critically reviewed CMC dossiers documents for development projects and
commercial product support (life-cycle management) within matrix environment (R&D, Project
Management, QA and Manufacturing).
 Responsibilities include Reg CMC strategy & risk assessment, preparation/review of high quality
global CMC submissions, responses etc.
 Support registration of new pharmaceutical products.
 Manage/provide regulatory and technical oversight in area of responsibility to ensure timely
submission and approval of CMC regulatory documentation (including product submissions (new
applications and amendments & Supplement), and deficiency responses.
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3.  Provide quality regulatory and compliance advice, consultation and support.
 Participates in agency meetings as appropriate.
 Develop and maintain regulatory strategy documents.
 Defines and implements CMC regulatory product/project strategies.
 Proposes new/revised policies and recommends standard interpretation of regulations.
 Develops and implements internal and external strategies to proactively address changes in the
regulatory environment
 Provide technical advice to prepare and review regulatory submissions
 Provide regulatory strategy advice to internal and external candidates
 Provide project specific GRA (Global Regulatory Affairs) strategy
 Tracks implementation of commitments to health authorities
 Screens official websites for new guidelines and changes in legislation and shares with group
functions.
 Elevate any serious quality issues to Group Quality for action.
 Compliance of Lab GMP and Data Integrity.
 Review of submission data to be sent from CRA.
 Compliance of OOS, OOT, Change Controls, Incidents, Deviations etc.
 Compliance of previous regulatory, consultants, customer and internal audits
 Compliance of commitments given to Regulatory agencies as part of ANDA, CR, IR etc.
JOB PROFILE IN PT.BERNOFARM
Working International Regulatory Affairs at PT. Bernofarm, nine months as an Asst. Manager (Since
Dec’13 –Aug’14)
 1.Develop new regulatory policies; processes and SOPs and train key personnel on them
 2. Evaluate regulatory risks of division policies; processes; procedures
 3.Provide regulatory input to product life cycle planning
 4.Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory
management
 5.Assist in the development of multi country regulatory strategy and update strategy based upon
regulatory changes
 6.Assist in regulatory due diligence for potential and new acquisitions
 7. Utilize technical regulatory skills to propose strategies on complex issues
 8. Determine submission and approval requirements and Identify emerging issues
 9. Monitor trade association positions for impact on company products
 10. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and
develop solutions with other members of regulatory and related teams
Working in Regulatory Affairs at SUN Pharmaceutical Ltd., two years six months as an Executive
 1.Preparation and compilation of ANDA documents (CMC section) in eCTD format for ANDA
products.
 Compilation and Review of Raw material test methods, test data, Process validation report, Batch
Manufacturing Record and Batch Packing Record.
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JOB RESPONSIBILITY
JOB PROFILE IN SUN PHARMACUTICAL LTD.,
JOB RESPONSIBILITY

4.  Independently Prepared Modules 2 and 3 of ANDA Submission in CTD format.
 Compiled and submitted deficiency responses for ANDA amendments and supplements.
 Response the CMC deficiencies in stipulated time frame (Minor, Major and Telephonic).
 Worked with different cross-functional teams including formulation development, analytical,
quality complacence, project management, R&D team, commercial team, and R&D operations on
several projects to develop new products.
 Managed multiple projects in support of departmental plan: Independently planned, managed, and
completed technical programs necessary to design, development and optimization of new
products.
 Review of product development report as per revised ICH Q8, Q9&Q10 guidelines and try to
implementing design space and quality by design concept.
 Proven ability to effectively manage time and multiple projects, contribute effectively to project
teams, achieve deadlines and collaborate with colleagues on a global level.
 Additionally, inform the team of any potential issues which may affect the critical quality
attributes in the product.
 Contributed to the strategy, drafting and review of documents and labeling for the ANDA
registration.
 Keep up to date knowledge of various guidelines, regulatory affairs and technical aspects as per
market trends.
 Interact cross functional team member for resolving technical issues.
 Ensured that local and international websites were monitored and updates regularly distributed to
key stakeholders.
JOB PROFILE IN MACLEODS PHARMACEUTICALS LTD.
Working in Regulatory Affairs at Macleod’s Pharmaceutical Ltd.
JOB RESPONSIBILITY
 Compiled and submitted deficiency responses for ANDA amendments and supplements.
 Response the CMC deficiencies in stipulated time frame (Minor, Major and Telephonic).
 Review of product development report as per revised ICH Q8, Q9&Q10 guidelines and try to
implementing design space and quality by design concept.
JOB PROFILE IN WOCKHARDT LTD.
Worked in Global scientific & Drug Regulatory Affair at Wockhardt Ltd.
JOB RESPONSIBILITY
 Independently Prepared Modules 1, 2 and 3 of ANDA Submission in eCTD format.
 Preparation and compilation of ANDA documents (CMC section and Labeling section) in CTD
format for liquid oral ANDA products.
 3.Compilation and Reviewed of Raw material test methods, test data, Process validation report,
Batch Manufacturing Record and Batch Packing Record.
 Preparation of packaging materials documents, Preparation of side by side label and carton
comparison, Review and update information for package inserts.
 Preparing Amendments, Supplements and Annual Reports for ANDA’s.
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5.  Preparing and Maintaining Change Control documents as per the SOP and Current FDA
guidelines.
 To co-ordinate research & development activities relating to pre-formulation evaluation and
development of formulation.
 Wrote and reviewed SOPs, change controls as well as other documents, and participate in training.
JOB PROFILE IN ORCHID HEALTH CARE LTD.
Worked in Quality Assurance & Compliance at Orchid Health Care Ltd (Currently Hospira Health Care).
JOB RESPONSIBILITY
 Well versed in cGMP requirement for the pharmaceutical industry and proficiently executed
cGMP manufacturing of exhibit and commercial batches for sterile and nonsterile product.
 Played an active role as a team member of different teams that are formed to update the
Formulation development area, manufacturing area and quality assurance area as per cGMP
(compliance the 21CFR 210 and 211) requirements.
 Review the Batch manufacturing record and Batch packing record.
 Faced various regulatory audits like USFDA, Pfizer and Sandoz etc.
 Assessed change controls and prepared submissions arising from the change control process.
 Reviewed documents including SOPs, analytical procedures and validation and stability protocols
and reports.
 Experience in internal auditing and validating cGMP requirements at Manufacturing Units
(production).
 Coordination with Regulatory Department to providing documents (Exhibit) for ANDA
submission.
 Preparation of manufacturing documents such as Manufacturing Process Validation protocols and
Reports, Post Approval Protocol, Proposed Batch Records (up to 10 folds), equipment comparison
chart, etc.
 Preparing and Maintaining Change Control documents as per the SOP and Current FDA
guidelines.
EDUCATIONAL QUALIFICATION
Qualification University Year
Pursuing External PhD
(Pharmacy)
Annamalai University, Chidambaram, Tamil
Nadu.
2010- Till
date
Master of Pharmacy (Quality
Assurance).
Annamalai University, Chidambaram, Tamil Nadu. 2003-2005
P.G. Diploma in Personal
Management and Industrial
relation.
Annamalai University, Chidambaram, Tamil Nadu. 2003-2004
P.G. Diploma in Foreign Trade. Annamalai University, Chidambaram, Tamil Nadu. 2004-2005
Bachelor of Pharmacy Rajiv Gandhi University, Karnataka. 1999-2002
Bachelor of Science Burdwan University, West Bengal. 1996-1998
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6. ACHIEVEMENTS
• Presented paper in ICIPG (International Congress of Pharmacy Graduates 2003) of SIX SIGMA
CONCEPTS INDUSTRIES –AN OVERVIEW.
• Presented paper in IPC (India Pharmaceutical Congress Kolkata -2004 of EVALUATION
OF STABILITY OF A PROCESS IN PHARMACEUTICAL INDUSTRY BY SIX SIGMA
CONCEPT.
WORKING EXPERIENCE
Organization Duration
Glenmark Pharmaceutical
Ltd. (GoA, India)
Two years as Manager (Since Sept’14 -Till date)
PT.BERNOFARM (Surabaya,
Indonesia)
Nine months as an Asst. Manager (Since Dec’13 –Aug’14)
SUN Pharmaceutical Ind. Ltd.
(Vadodara, India)
Two years six months as an Executive (Since June’11 -Nov'13)
Macleod’s Pharmaceutical Ltd.
(Mumbai,India)
One year seven months as an Asst. Manager (Since Nov’09 –May’11)
Wockhardt Ltd.
(Aurangabad,India)
One year seven months as an Executive (April’08- Nov’09 )
Orchid Health Care Ltd.
(Chennai,India)
Two years nine months as an Executive ( July’05 – March’08)
Sanofi-Aventis (Goa,India) Six months Dissertation as part of Master in Pharmacy programmed
(Sep’04 – March’05)
INITIATIVES TAKEN
Maintaining Daily Reports of the Team members. Strategic planning to bring products to market and
advise other departments within the business on regulatory matters.
Review of processes and procedures to improve efficiency and results within the department.
Maintain and develop relationships with local and international regulatory bodies.
STRENGHTS
Honest excellent Interpersonal skills.
Timely provision of service and documentation.
Meeting submission and approval registration plans.
Provision of viable regulatory strategies.
Timely resolution of regulatory issues and challenges.
Colleague and team engagement.
Good team player, listener and motivator.
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7.  Always believe in commitment and consistency.
 Highly self-motivated, Quick learner and proactive.
 Willing and able to handle wide variety of tasks simultaneously.

COMPUTER PROFICIENCY
Working knowledge of Basics of computer, MS-office, Excel, eCTD (Pharmaready), Adobe Acrobat
(Advanced) etc.
PERSONAL PROFILE
Date of Birth : September 6th 1976
Sex : Male
Language Proficiency : Bengali, Tamil, Hindi & English
Nationality : Indian
Religion : Hindu
Marital status : Married
REFERENCE
 Mr. Rakesh Chaurasia, Head of Regulatory Affairs, PT.DEXA-MEDICA, Tangerang,
Indonesia, Mobile No. +62-81290368046.
 Dr. Abhay Muthal, Vice President, Regulatory Affair dept. SUN Pharmaceutical Ltd.
Vadodara, India. Mobile No. +919909969532.
The above mention data’s are true to the best of my knowledge and understanding.
Thanking you,
Santanu Roy
Place: GoA, India
Date:22/08/2016
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DECLARATION