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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