Rahul Raj
@rahulraj6
Regulatory Affairs Manager with 13+ years driving FDA-compliant submissions, quality, and risk-focused compliance across global markets.
GermanyWhat I'm looking for
I’m a dedicated pharmacist and Regulatory Affairs professional with 13+ years of experience in Regulatory Affairs and Compliance. I’ve built a strong track record navigating complex regulatory landscapes and ensuring compliance with FDA regulations, supported by deep expertise in regulatory submissions, quality assurance, risk assessment, clinical trials, regulatory strategy, change control, ICH guidelines, and labelling and promotional material review.
In my current role as a Manager in Regulatory Affairs at Glenmark Pharmaceuticals, I support product life cycle management for eCTD submissions and RIMS, handling registrations across the US, EU, Canada, Australia, and South Africa. I manage annual reports and post-approval variations (CBE-30/PAS and EU responses), lead data and dossier-quality monitoring through peer review, and collaborate with cross-functional teams to deliver on time and within budget—while also supporting RA & Safety teams with periodic reports.
Experience
Work history, roles, and key accomplishments
Manager in Regulatory Affairs
Glenmark Pharmaceuticals Ltd
Oct 2019 - May 2026 (6 years 7 months)
Provided product life-cycle management support for eCTD submissions and RIMS, handling registrations and post-approval activities across US, EU, Canada, Australia, and South Africa. Managed regulatory publishing and quality review of product registration profiles, and supported authority/internal ad-hoc queries and periodic reporting for RA and Safety teams.
Lead Consultant in Regulatory Affairs
Genpact Pharmalink
Sep 2017 - Oct 2019 (2 years 1 month)
Managed regulatory submissions for US-based clients (Merck), including initiation, maintenance, planning, and execution. Prepared FDA annual reports, coordinated product change summaries, and supported publishing and submission planning activities for final acknowledgments.
Senior Executive in Regulatory Affairs
iMEDGlobal Corp
Oct 2014 - Sep 2017 (2 years 11 months)
Managed European regulatory projects for Johnson & Johnson, administering DMS/RIMS for pharma and cosmetics dossiers including CMC parts, labels, and SmPC translation compliance. Prepared global product dossiers and developed an eCTD publishing tool (Docubridge) with gap analysis coordination to support publishing readiness.
Senior Regulatory Executive
Imres B.V Pharmaceutical Company
Dec 2010 - Oct 2014 (3 years 10 months)
Compiled regulatory dossiers per ACTD and CTD guidelines and coordinated with manufacturers (e.g., Cipla, Alembic, Fresenius-Kabi, Claris, Mylan, HML) to meet submission timelines and ICH-aligned documentation. Developed SOPs/work instructions for emerging ROW markets, sourced WHO-GMP/MHRA-approved vendors, and supported country-specific dossier preparation including PSS creation and related docum
Drug Regulatory Affairs Officer
Akums Drugs and Pharmaceuticals Ltd
Jun 2010 - Nov 2010 (5 months)
Created, reviewed, and compiled country dossiers for emerging markets in accordance with regulatory requirements, gathering technical materials such as stability and safety study documentation. Supported cross-functional teams in assembling dossiers aligned to regional regulatory strategies and business objectives.
Education
Degrees, certifications, and relevant coursework
Shri Venkateshwara University
Doctor of Philosophy in Pharmaceutical Science, Pharmaceutical Science
Earned a Doctor of Philosophy in Pharmaceutical Science at Shri Venkateshwara University in 2018.
Singhania University
Master of Pharmaceutical Science in Pharmaceutics, Pharmaceutics
Earned a Master of Pharmaceutical Science in Pharmaceutics at Singhania University in 2010.
WIPO Academy
General Certificate in Intellectual Property Rights, Intellectual Property Rights
Earned a General Certificate in Intellectual Property Rights from the WIPO Academy in Geneva in 2009.
S.D. College Of Pharmacy & Vocational Studies
Bachelor of Pharmaceutical Science, Pharmaceutical Science
Completed a Bachelor of Pharmaceutical Science at S.D. College of Pharmacy & Vocational Studies in 2008.
Availability
Location
GermanyAuthorized to work in
Job categories
Skills
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