Opening in Regulatory Affairs

1 week ago

Mumbai, Maharashtra, India Ms. Crescent Pharma Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

New submissions

Preparation, Registration & Submission of Dossiers to EU or UK and other regulated markets.

Compilation and review of Type IA/IB/II Regulatory Variations.

e.CTD publication of variation applications/PIQ/Renewal/New applications

Preparation/Submission of Change of Ownership applications, Piggyback application etc.

Submission of variation applications using the relevant country organization portals including CESP.

Post-approval life cycle management

End-to-end post-approval life cycle management for regulated markets

Handling variation submissions and renewal submissions for EU and UK

Expertise in Module 1 and Module 3 documentation

Coordination with internal teams and regulatory agencies to ensure compliance

Updating dossiers and ensuring timely submissions.

Preferred candidate profile

For UK and Europe market only

Intrested candidates please share profile on

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