Sun Pharmaceutical Inds Limited
Opening in Regulatory Affairs – Branded
Qualification: M.Pharm / M.Sc in Biotech
Grade: Executive / Sr. Executive
Job Location: Baroda / Mumbai / Gurgaon
1) This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed biological products across the globe. Regulatory activities focus on filing activities/query responses/post-approval changes as suggested across the 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 of 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 with senior management.
8) Responsible for the preparation of IND and IMPD documents
9) Providing consistent support to commercial and clinical teams.
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