Intas Pharmaceuticals is a leading global pharmaceutical company dedicated to developing, manufacturing, and marketing high-quality formulations. With a presence in over 85 countries, Intas operates under the well-known brand Accord Healthcare in key markets like the US, Europe, Latin America, and Asia-Pacific.
The company is committed to addressing unmet medical needs through cutting-edge R&D, including biosimilars and New Chemical Entities (NCEs). Intas maintains high regulatory compliance, with approvals from USFDA, MHRA, and EMA, ensuring global standards of quality and safety.
Job Title: Senior Executive – Regulatory Affairs
Job Requisition No.: 13246
Location: Biotech, Ahmedabad, Gujarat
Experience: Relevant experience in regulatory affairs (biosimilars preferred)
Job Description
Purpose of the Job
The Senior Executive – Regulatory Affairs will be responsible for handling dossier requests from internal business partners, ensuring compliance with regulated and semi-regulated markets.
Key Responsibilities
- Authoring IMPD and MAA for biosimilar product registrations in EU, US, and ROW regions.
- Preparing scientific advice and briefing book documents for biosimilars.
- Drafting and submitting responses to regulatory queries.
- Collaborating with Cross-Functional Teams (CFTs) for CMC document preparation.
- Maintaining regulatory trackers and ensuring timely updates.
- Providing regulatory assessments for change controls.
Skills & Qualifications Required
- M.Pharm / B.Pharm from a reputed university.
- Experience in handling biosimilar registrations in regulated markets.
- Strong knowledge of drafting dossier sections & query responses.
- Familiarity with regulatory tools and guidelines (USFDA, EMA, MHRA).
- Excellent communication & problem-solving skills.
Desired Competencies
✅ Action-Oriented
✅ Customer Focus
✅ Problem-Solving
✅ Time Management
✅ Ability to Work in Ambiguity
Why Join Intas Pharmaceuticals?
- Work with a globally recognized pharmaceutical leader.
- Be part of innovative R&D in biosimilars and NCEs.
- Career growth opportunities in a dynamic work environment.
- Competitive salary & benefits.
How to Apply?
Interested candidates can apply by sending their updated resume to careers@intaspharma.com with the subject line “Application for Senior Executive – Regulatory Affairs (Req. ID: 13246)”.
