Sentiss Pharma - Manager - Regulatory Affairs

Manager - Regulatory Affairs

SUMMARY OF THE OVERALL JOB:

- Overall responsible for end-to end-dossier compilation, review and handling of response to queries for emerging markets including Russia/CIS.

- Life cycle management for registered products

KEY RESULT AREAS:

- Compilation & Review of dossiers on time for emerging markets in compliance with country specific requirements.

KEY FUNCTIONS / 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

EDUCATION AND EXPERIENCE:

- M.Pharm from Reputed institutes

- Must to have: Min. 5 years hands on experience for handling EU, AUS and Russia-CIS region

- Experience of Emerging markets like GCC, Brazil, China, S. Korea etc .

- CE certification for Medical device registration is an added advantage.