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Opening as Senior Executive - Regulatory & Business Continuity - Branded at Sun Pharma




Clinical research courses

Opening as Senior Executive - Regulatory & Business Continuity - Branded at Sun Pharma

Sun Pharmaceutical Industries Limited is taking this opportunity to balance employment and the medications to the world. We are hereby inviting candidates who are interested to join India's No. 1 company in Pharmaceutical sector.

Post :  Senior Executive - Regulatory & Business Continuity - Branded

Job Description
- This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for New Drug Applications across globe. Regulatory activities focus on filing activities/query responses/post approval changes as suggested across globe.
- Person will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that timely and high quality regulatory submissions are made.
- Understanding global regulatory requirements, particularly for US/EU/Japan/China and rest of markets and sharing additional data generation/gap assessments with CFT
- Closely work with consultants, partners and local regulatory colleagues to understand regional requirements.
- Preparation of Agency consultation packages, briefing book and required presentations and engage with Agency for consultations
- Provide CMC support for other branded projects as needed.
- Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.
- Responsible for preparation of IND and IMPD documents
- Providing consistent support to commercial and clinical teams.

Candidate Profile
Education: M.Pharm
Department: Regulatory & Business Continuity - Branded

Additional Information
Qualification : M.Pharm
Location :  Gurgaon (preferable)/Baroda/Mumbai 
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory affairs
End Date : 20th June 2024

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