Regulatory Affairs Executive – API | USV | Mumbai

Job Description

• Collect / Prepare and file dossiers in a timely & accurate manner for Formulation & API products to get licenses from various targeted markets.
• Review & regulatory impact analysis of the change control, communication with customer for notification and approval as applicable
• Review and regulatory impact analysis of the changes notified by the vendor as per current regulatory requirements (country-specific), as desired.
• Evaluate any changes proposed post-approval. Prepare and file necessary amendments/ supplements/ annual reports as applicable to ensure regulatory compliance (Post-approval Life Cycle Management)
• Prepare the checklist for documentation for regulatory fillings as per current regulatory requirements.
• Collect & conduct a first-level review/ overview of relevant standard technical documentation like stability, TTD, PDR, and method validation.
• Conduct initial review of labeling/ artwork as per the market where the dossier is being filed
• e-CTD compilation/ publishing of DMF/ Dossier & Submission to customer/ Health Authorities
• Assist in the resolution of queries received from customers/agencies/regulators and assess them before sharing them with the team leader
• Preparation of Tech-packs for APIs
• Prepare & e-file documents for registration of any facility used (in process for drug) with the USFDA
• Submission of Renewals, Re-registrations, Tender

Qualification: MS/M.Sc(Science), M.Pharma