Asence Pharma Pvt. Ltd. is inviting applications for the position of Regulatory Affairs Executive at its facility in Ranoli, Vadodara, Gujarat. Candidates with M.Pharm, B.Pharm or M.Sc. qualifications in Pharmaceutical Regulatory Affairs, Organic Chemistry or a relevant discipline are eligible to apply.
The company is looking for professionals with 3–5 years of relevant experience in API manufacturing units. Candidates with a background in Quality Control (QC) will be preferred.
The selected candidate will support regulatory documentation, international submissions, regulatory database maintenance and post-approval change management.
Interested candidates can share their updated CV with the recruitment team by email.
Asence Pharma Regulatory Affairs Executive Recruitment
Company Overview
Asence Pharma Pvt. Ltd. is hiring a Regulatory Affairs Executive for its facility in Ranoli, Vadodara, Gujarat. The position focuses on regulatory documentation and submissions for active pharmaceutical ingredient (API) manufacturing operations.
Job Role & Responsibilities
Regulatory Affairs Executive
The selected candidate will support regulatory documentation, submission activities and coordination with internal departments.
Key responsibilities include:
- Assist in preparing regulatory documents, including Drug Master File (DMF) sections, Certificate of Pharmaceutical Product (CoPP), GMP and Certificate of Suitability (CEP) documentation.
- Collect and review technical and quality data from Research and Development (R&D), Quality Control (QC), Quality Assurance (QA) and Production departments.
- Assist with regulatory submissions across international markets and track approval status.
- Maintain regulatory databases, filing records and regulatory documentation.
- Coordinate responses to regulatory deficiencies and manage post-approval changes.
Eligibility & Qualifications
Candidates must meet the educational and experience requirements for the Regulatory Affairs Executive position.
Educational Qualifications:
- M.Pharm
- B.Pharm
- M.Sc. in Pharmaceutical Regulatory Affairs, Organic Chemistry or a relevant discipline
Experience Required: 3–5 years of relevant experience in API manufacturing units.
Preferred Background: Candidates with Quality Control (QC) experience will be preferred.
Location & Salary
Job Location: Ranoli, Vadodara, Gujarat.
Salary details have not been specified in the recruitment announcement.
How to Apply
Interested and eligible candidates can apply by sending their updated CV to the recruitment team.
Email: hr@asence.com
Candidates should include their educational qualifications, relevant API industry experience and current contact details in their CV.
Important Recruitment Details
- Company: Asence Pharma Pvt. Ltd.
- Designation: Regulatory Affairs Executive
- Department: Regulatory Affairs
- Location: Ranoli, Vadodara, Gujarat
- Experience: 3–5 years
- Preferred Candidates: Professionals with a Quality Control background
Frequently Asked Questions
1. What is the qualification required for the Asence Pharma Regulatory Affairs Executive position?
Candidates with M.Pharm, B.Pharm or M.Sc. in Pharmaceutical Regulatory Affairs, Organic Chemistry or a relevant discipline can apply.
2. How much experience is required?
Applicants should have 3–5 years of relevant experience in API manufacturing units.
3. Are QC professionals eligible to apply?
Yes. Candidates with a Quality Control background will be preferred.
4. Where is the job located?
The position is based in Ranoli, Vadodara, Gujarat.
5. How can candidates apply?
Candidates can email their updated CV to hr@asence.com.
6. What are the main responsibilities of this role?
The role involves regulatory documentation, international submissions, regulatory database maintenance, deficiency responses and post-approval changes.
Job Summary
| Category | Details |
|---|---|
| Company | Asence Pharma Pvt. Ltd. |
| Vacancies | Regulatory Affairs Executive |
| Required Education | M.Pharm / B.Pharm / M.Sc. in Pharmaceutical Regulatory Affairs, Organic Chemistry or a relevant discipline |
| Experience | 3–5 years in API manufacturing units |