Senior Executive - Regulatory Affairs
Job Requisition No.: 13246
Location: Biotech, Ahmedabad, Gujarat, India – 382213
Travel Requirement: 0%
Purpose of Job:
To manage and execute dossier requests from internal business partners, ensuring timely and accurate regulatory submissions for biosimilar products across regulated and semi-regulated markets.
Key Responsibilities:
Prepare regulatory submissions for both regulated and semi-regulated markets.
Author IMPD (Investigational Medicinal Product Dossier) and MAA (Marketing Authorization Application) by compiling required documentation for biosimilar registrations in EU/US/ROW regions.
Draft scientific advice and briefing book documents.
Develop query responses received from regulatory agencies.
Collaborate within regulatory teams for effective preparation of CMC (Chemistry, Manufacturing and Controls) documentation.
Update and maintain regulatory trackers to ensure accurate information management.
Provide regulatory assessments for change controls.
Skills Required:
Proven experience with biosimilar registrations in regulated and semi-regulated markets.
Strong capabilities in drafting dossier sections and query responses.
Effective coordination and communication with cross-functional teams (CFTs).
Familiarity with regulatory tools.
Excellent verbal and written communication skills.
Qualifications:
M.Pharm/B.Pharm from a reputed university.
Biological product experience is preferred.
Competencies:
Action Oriented
Customer Focused
Adaptable to Ambiguity
Strong Problem-Solving Skills
Effective Time Management
Life at Intas Pharmaceuticals:
At Intas, excellence is driven by people. For over 30 years, the organization has thrived through a collaborative culture that balances individual growth with collective achievement. Intas offers a dynamic environment that embraces innovation and diversity, enabling employees to deliver impactful work in the pharmaceutical industry.
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