Officer / Sr. Officer-Regulatory Affairs

Job Description

Role & responsibilities 1. Preparation & compilation of dossier in ACTD, CTD & country specific format according to guidelines of various countries. 2. Timely compile documents for license renewals, update and re-registrations. 3. Review of technical documents like BMR, Stability, Spec-STP,PVP-PVR,PDR required for dossier compilation. 4. Collect and co-ordinate information and compile regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy. 5. Response to query/deficiency/Notice of Deficiency raised by Drug Regulatory Authority or technical representative. 6. Stakeholder Engagement. 7. Cross-functional Collaboration. Preferred candidate profile M. Pharma (Pharmacy)/B.Pharma ( Pharmacy) Perks and benefits