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Opening in Regulatory Affairs at Sun Pharma - M.Pharm, MSc Apply


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Opening in Regulatory Affairs at Sun Pharma

Sun Pharma is the fifth largest generic pharmaceutical company in the world. It is also India's largest and most valuable pharmaceutical enterprise by size and market capitalization. The company provides high-quality medicines trusted by customers and patients in over 150 countries and has multiple manufacturing facilities and R&D centres.

Opening in Regulatory Affairs - Branded

Qualification : M.Pharm / M.Sc in Biotech
Grade : Executive / Sr. Executive
Job Location : Baroda / Mumbai / Gurgoan

Job Description
1) This position will support and manage the regulatory activities associated  with the Chemistry, Manufacturing and Controls for licensed biologic products across globe. Regulatory activities focus on filing  activities/query responses/post approval changes as suggested across  globe.
2) Incumbent will be responsible for assuring the  established regulatory strategy is aligned with Health Authority  requirements from a global perspective and assuring that regulatory  submissions are on time and high quality.
3)  Understanding country  specific requirements, particularly for EM, and sharing additional data  generation/gap assessments with CFT
4)  Closely work with consultants, partners and local regulatory colleagues to understand regional requirements.
5) Preparation  of Agency consultation packages, briefing book and required  presentations and engage with Agency for consultations 
6)  Provide CMC support for other branded projects as needed.
7) Additional  duties include coordination with our global manufacturing sites,  integration of regulatory strategy with those sites and communication to  senior management.
8) Responsible for preparation of IND and IMPD documents 
9) Providing consistent support to commercial and clinical teams.

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Last Date : 25th April, 2023

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