Ra Executive

1.Manageable knowledge on the regulatory and quality guidelines from various regulatory agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.

3. Hands on experience on preparation of drug master files, life cycle management and drafting of response to deficiencies and customer DMF review comments for all global regions.

4. Should have knowledge on product developmental and the quality systems to ensure the regulatory compliance.

5. Should have hands on experience on eCTD regulatory submission tools.

6. Conducting meetings for the deficiencies received from various regulatory agencies and should have knowledge on the requirements to respond to the deficiencies. Ensuring that the accurate and adequate responses are sent to the authorities within the timelines defined by agencies.

7. Thorough review and ensuring that the regulatory submissions are adequate and error free with minimum open issues and closing of open issues before filing or before the receipt of deficiencies.

8. Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.

9. Reviewing the documents received from various departments R&D, AR&D, QA, QC and Production etc at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.

10. Review and assessment of change controls and providing guidance to the team n proposed changes.

11. Ensuring that the regulatory databases are properly maintained and updated on time to time for each regulatory activity.

**Salary**: ₹300,000.00 - ₹450,000.00 per year

Schedule:

- Day shift
- Fixed shift
- Morning shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Raigarh Fort - 410208, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 3 years (preferred)