At HOF Pharmaceuticals Limited, we are sincerely dedicated to improving the health and well-being across the world by innovating and delivering high-quality pharmaceutical products. We are a leading manufacturer & exporter of Tablets, Capsules & Oral Liquids. Join our team and be a part of our mission to deliver high-quality pharmaceutical products for a better tomorrow.
Post: Regulatory Affairs - Senior Executive (International Regulatory Affairs)
KEY RESPONSIBILITIES
- Prepare, compile, review, and coordinate CTD/ACTD/eCTD regulatory dossiers for pharmaceutical products for international markets.
- Coordinate regulatory submissions, approvals, renewals, variations, and post-approval activities across assigned countries.
- Review product development and technical documents for regulatory compliance and identify documentation gaps.
- Coordinate with R&D, QA, QC, Production, Medical, Pharmacovigilance, Supply Chain, and Business Development teams for dossier preparation.
- Prepare and review regulatory documents.
- Review country-specific regulatory requirements and ensure dossiers comply with applicable local guidelines.
- Respond to regulatory authority deficiencies, queries, and clarification requests in coordination with relevant technical departments.
- Track submission status, regulatory timelines, deficiency responses, approvals, renewals, and commitments.
REQUIREMENTS
- 7 to 8 years of experience in Regulatory Affairs with exposure to RoW / emerging markets.
- B.Pharm / M.Pharm / M.Sc. (Pharmaceutical Sciences) or related field.
- Good understanding of international regulatory requirements and dossier preparation (CTD/ACTD/eCTD).
- Exposure to multiple markets in Asia, Africa, LATAM or other emerging markets (RoW preferred).
- Strong regulatory knowledge, analytical skills and attention to detail.
- Good communication, documentation and coordination skills.
- Ability to work independently and collaboratively in a cross-functional team.
Location: Thaltej, Ahmedabad
Experience: 7 to 8 years
(RA experience of RoW / emerging market)
Email your resume to: hr@hofpharma.com
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