Crescent Pharma
10–15 Years
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Position: Regulatory Affairs Professional – Post-Approval Life Cycle Management (Variation)
📍 Location: Thane (Work from Office – 5 Days/Week)
🎓 Qualification: B.Pharm / M.Pharm / M.Sc.
💼 Experience: 10–15 Years
Looking to advance your career in Regulatory Affairs? An exciting opportunity is available for experienced professionals specializing in Post-Approval Life Cycle Management (Variation) for the UK & Europe markets.
Key Responsibilities:
* Manage end-to-end post-approval life cycle activities for regulated markets.
* Handle variation and renewal submissions for the UK and EU.
* Prepare and review Module 1 & Module 3 documentation.
* Coordinate with internal cross-functional teams and regulatory authorities.
* Support artwork, PIQ, safety submissions, and sunset exemption activities.
* Perform change control assessments and manage MRP/DCP variation procedures.
* Conduct product launch GAP analysis and impact assessments.
If you have extensive experience in EU/UK regulatory submissions and lifecycle management, this could be an excellent opportunity to take the next step in your career.
FYND Talent Solutions is an independent recruitment platform. This job is shared for informational purposes only and is not an official communication from the hiring company unless explicitly stated.
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