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.
Send in your resume to : Rosemary.varghese@sunpharma.com
Last Date : 25th April, 2023
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