Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5.1 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.
Name of Post: Regulatory Affairs Branded ( Biosimilar )
Qualification: M. Pharm/ M. Sc in Biotech
Designation: Executive / Sr. Executive
Job Location: Baroda / Mumbai / Gurgoan
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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