Regulatory Affairs Executive

2 weeks ago

Mumbai Maharashtra, India Acme Services Full time

Roles and Responsibilities

1. Management of product lifecycle for Europe market

2. Dossier Preparation

3. Query Response

4. Post Approval changes

5. Variation Filing

6. Coordination with cross functional team

Role Description: Product registration and life cycle management for Europe

Qualification: B.Pharma/M.Pharma with about 4 - 15 years’ experience in RA and other dept.

**Job Description**:
2.Preparation of respective CTD sections and submission of final query response to agency

3.Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval

4.To upload documents in national portal for respective European regulatory agency

6.Review of the mockups for all regulatory submissions and commercial supplies

7.Maintenance of internal database

8. Co-ordination with consultant for national submissions, product information translation, readability testing etc

9. Review and approval of change control and deviations

11. Review of variation packages

**Job Types**: Full-time, Permanent

**Benefits**:

- Health insurance
- Life insurance

Schedule:

- Day shift

Supplemental pay types:

- Commission pay
- Overtime pay
- Performance bonus
- Quarterly bonus
- Yearly bonus

Ability to commute/relocate:

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

Application Question(s):

- Which Market you handle

**Experience**:

- total work: 4 years (preferred)

Work Location: In person

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