Regulatory Affairs Executive

6 days ago

Odhav Ahmedabad Gujarat, India Prime Placement Full time

**Position**: Regulatory Affairs - Senior & Junior
**Qualification**: B.Pharm / M.Pharm
**Experience**: 3-4 years in the same department
**Openings**: 1 Senior, 2 Junior
**Salary Range**: ₹30,000 - ₹50,000 per month (based on experience)
**Location**: Ahmedabad

**Key Responsibilities**:

- Review dossiers prepared by executives/trainees and submit to clients along with artworks for markets such as Asia, LATAM & ROW.
- Handle renewals of Registration Certificates for various countries.
- Ensure compliance of products with current ICH and country-specific guidelines.
- Arrange and courier legalized documents (COPP, FSC, POA, Manufacturing Agreements, Declaration letters, GMP certificates) to clients/countries.
- Coordinate the courier of samples for new registrations and renewals for reanalysis and commercial batch testing.
- Arrange required samples and legal documents from Legal, Production, and FRD teams.
- Follow up with FRD and Microbiology departments for client-specific testing requirements.
- Arrange and dispatch Working Standards from QC to clients/countries for testing purposes.
- Resolve client queries related to new registrations and renewals in accordance with country requirements.
- Maintain country-specific global status sheets for new registrations, renewals, and query status.
- Coordinate with the Artwork department for review and corrections of artworks for new registrations and renewals.
- Follow up and arrange documents for dossier preparation from QA, QC, ARD, and Microbiology departments as per guidelines.

**Desired Skills**:

- Strong knowledge of regulatory documentation and country-specific guidelines.
- Excellent coordination, follow-up, and communication skills.

Detail-oriented with the ability to handle multiple projects simultaneously.

**With Regards,**
**Himani(HR)**
**9377165778**

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

Pay: ₹25,000.00 - ₹50,000.00 per month

Work Location: In person

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