SACHIN CHOUDHARI
Ahmedabad
Summary
A highly skilled Regulatory and Quality specialist with a postgraduate degree in Pharmacy and over nine years of experience in the pharmaceutical industry. Currently excelling in the Drug Regulatory Affairs Department, specializing in technical document review, data compilation (eCTD), and post-approval activities. Well-versed in the life cycle management of generic pharmaceutical products for the European and UK markets. Eager to leverage expertise in a new professional opportunity to further develop skills and contribute effectively.
Overview
10
10
years of professional experience
Work History
Assistant Manager – Drug Regulatory Affairs
Intas Pharmaceuticals Limited
12.2023 - Current
- Prepare, compile, review and submit the high-quality submissions for all required post-approval activities Moduel-1, Module-2 and Module-3 (Quality, Safety and administrative) in accordance with EU, UK legislation and in-house standards.
- Submission of Renewals as per defined plan.
- To prepare and review responses to queries of the Quality, Safety variations and Renewals.
- Involvement in change control assessment and execution as per regulatory prospectives.
- Performing gap assessment of approved dossier vs current practices applied in manufacturing site for submission in new countries.
- To address gaps in documents in agreement with stakeholders ensuring minimal impact on business.
- Participate in meetings with stakeholders on a regular basis on projects.
- Co-ordinate with all the cross-functional teams to arrange the documents for regulatory submissions.
- Experience of work-sharing and supergrouping variations submissions.
- Timely highlight the concerns /issues/non-compliance to the reporting manager.
- Tracking of variation approvals, maintaining lifecycle of procedures by keeping updated various database like VEEVA Vault, PharmaReady, summary sheets, working folder and variation folders.
- Maintaining the RIMS database for Regulatory Submissions & approvals on regular basis.
Eexecutive Drug Regulatory Affairs
Tevapharm India Pvt Ltd
01.2022 - 12.2023
- Maintaining the Post approval maintenance activities for the MRP & DCP procedures.
- Prepare, compile, review and submit the high quality submissions for all required post-approval activities (Quality, Safety and administrative) in accordance with EU legislation and in-house standards.
- Ensure approvals are secured within the stipulated timelines for designated projects. Life cycle management of Marketing Authorizations (MAs)
- Maintaining lifecycle of procedures by keeping updated various database like VEEVA Vault, ADAM, GI, summary sheets, working folder and variation folders
- Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
- Priorities, plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress.
- Review and monitor submissions of Public Assessment Reports received from authority.
- Submission of Renewals as per defined plan.
- Experience of work-sharing and supergrouping variations submissions.
- Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
- Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
- Maintain and develop awareness of current/pending regulatory legislation and guidelines.
- Fulfilling other allocated department duties and ad-hoc needs at the direction of Senior Regulatory Affairs personnel.
Jr. Executive Drug Regulatory Affairs
Macleods Pharmaceuticals Limited
02.2020 - 01.2022
- Compilation and submission of registration dossier to Health Canada, WHO-PQ, ROW-SEA Market and Procurement Agency.
- Submission of Post Approval Changes (Variations) of the approved products.
- Addressing the query as per query received from Health Canada, WHO-PQ & ROW-SEA Market with reference to submitted dossier and variation.
- Requalification of Prequalified dossier.
- Product life cycle management of the approved products.
- Review & regulatory impact analysis of the Change Controls, Deviation, Batch Process Conversion, Product Quality Review and approval as applicable.
- Conduct initial review of the technical documents: Raw material specification, Finish product specification, BMR, PDR, Analytical Method validation, Stability study protocol/ report, Process validation protocol and report.
- Conduct initial review of labelling / artwork as per the market where the dossier is being filed (only formulations).
Senior Officer CQA
Macleods Pharmaceuticals Limited
07.2017 - 01.2020
QA Officer
Encube Ethicals Pvt Ltd
04.2016 - 07.2017
QA Trainee
USV Private Limited
04.2015 - 04.2016
Education
Bachelor of Science - Pharmaceutics
Padm. Dr. D. Y. Patil IPSR
Pimpri, Maharashtra01.2014
Bachelor of Pharmacy -
YBCCP
Aurangabad, Maharashtra01.2012
Skills
- Regulatory Compliance
- Regulatory Submissions
- Regulatory Publishing
- Document Management
- Project Coordination
- Risk Assessment
- EU Regulations
- Quality Management Systems
Websites
Personal Information
- Date of Birth: 10/05/89
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars.
Strengths
- Project Management, Successfully managed and coordinated multiple regulatory projects, ensuring adherence to timelines and budgets.
- Attention to detail, Demonstrated meticulous attention to detail while reviewing and preparing regulatory documents and submissions.
- Communication, Proven ability to communicate effectively and build positive relationships with cross functional teams, regulatory agencies and stakeholders.
- Problem Solving, Effectively resolved complex regulatory issues by analyzing and synthesizing information from multiple sources and proposing innovative solutions.
Timeline
Assistant Manager – Drug Regulatory Affairs
Intas Pharmaceuticals Limited
12.2023 - Current
Eexecutive Drug Regulatory Affairs
Tevapharm India Pvt Ltd
01.2022 - 12.2023
Jr. Executive Drug Regulatory Affairs
Macleods Pharmaceuticals Limited
02.2020 - 01.2022
Senior Officer CQA
Macleods Pharmaceuticals Limited
07.2017 - 01.2020
QA Officer
Encube Ethicals Pvt Ltd
04.2016 - 07.2017
QA Trainee
USV Private Limited
04.2015 - 04.2016
Bachelor of Pharmacy -
YBCCP
Bachelor of Science - Pharmaceutics
Padm. Dr. D. Y. Patil IPSR
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