Asst Manager/ Manager- Regulatory Affairs

Summary of the Job

Overall responsible for end-to end-dossier compilation, review and handling of response to queries for Russia/CIS, Ukraine and EU. Experience of Australia / Canada is an added advantage and its life cycle management for drug products.

Compilation of technical files for medical devices as per MDR expectations

Key Responsibilities

1. Review of documents for dossier compilation viz. development documents, tech transfer documents, Validations ( analytical method validation, filter validations etc), DMFs as well as all requisite product documentation required for filing of registration dossiers in Stringent regulatory authorities like Australia, EU, Eurasian Union and emerging markets for Sterile products (eye drops, ear drops, inhalations, injections, dosage forms).

2. Compilation, review and end to end tracking for filing of CTD dossier in markets like Europe, Australia, Eurasian union and emerging markets.

3. Handling of Product life cycle management activities viz. variations, renewals, notification, annual reports.

4. Handling of Product life cycle management activities viz. variations, renewals, notification, annual reports, PVG compliance submission.

5. Review of change controls, deviations, CAPA and interlinked QMS documents.

6. Compilation and updations of Medical Device Technical Files.

7. To assist for GMP application filing