Asence Pharma Pvt. Ltd. is hiring for the position of Regulatory Affairs Executive at its location in Ranoli, Vadodara, Gujarat. Candidates with an M.Pharma, B.Pharma, or M.Sc. in a relevant discipline and 3–5 years of experience in API manufacturing units can apply.
Candidates with a Quality Control (QC) background will be preferred.
Job Details
| Particulars | Details |
|---|---|
| Company Name | Asence Pharma Pvt. Ltd. |
| Job Position | Regulatory Affairs Executive |
| Job Location | Ranoli, Vadodara, Gujarat |
| Qualification | M.Pharma / B.Pharma / M.Sc. |
| Experience | 3–5 years |
| Industry Experience | API manufacturing units |
| Preferred Background | Quality Control (QC) |
| Application Email | hr@asence.com |
Position
Regulatory Affairs Executive
The selected candidate will support regulatory documentation, international regulatory submissions, compliance records, and coordination of regulatory activities with internal departments.
Key Responsibilities
- Support the preparation of regulatory documents, including Drug Master File (DMF) sections, CoPP, GMP, and CEP documentation.
- Collect and review technical and quality data from R&D, QC, QA, and Production departments.
- Assist with regulatory submissions across international markets and track approval status.
- Maintain regulatory databases, filing records, and regulatory documentation.
- Coordinate deficiency responses and post-approval changes.
Eligibility and Qualifications
Candidates applying for the Regulatory Affairs Executive position should meet the following requirements:
- Educational Qualification: M.Pharma, B.Pharma, or M.Sc. in Pharmaceutical Regulatory Affairs, Organic Chemistry, or a relevant discipline.
- Experience: 3–5 years of relevant experience in API manufacturing units.
- Preferred Experience: Candidates with a Quality Control (QC) background will be preferred.
Required Skills and Knowledge
- Regulatory documentation, including DMF, CoPP, GMP, and CEP.
- Collection and review of technical and quality data.
- Regulatory submission support for international markets.
- Regulatory database and filing record maintenance.
- Coordination of deficiency responses and post-approval changes.
How to Apply
Interested and eligible candidates can share their updated CV with Asence Pharma Pvt. Ltd. by email.
Email: hr@asence.com
Subject suggestion: Application for Regulatory Affairs Executive – Vadodara