Asence Pharma Pvt. Ltd. is inviting applications for the position of Regulatory Affairs Executive at its facility in Ranoli, Vadodara, Gujarat. This opportunity is suitable for pharmaceutical professionals with 3–5 years of relevant experience in API manufacturing who are looking to advance their careers in regulatory affairs and international regulatory submissions.
Candidates with a background in Quality Control (QC) will be preferred. Interested and eligible applicants can submit their updated CV directly to the company’s recruitment team via email.
Asence Pharma Regulatory Affairs Executive Job Details
Company Name
Asence Pharma Pvt. Ltd.
Job Role
Regulatory Affairs Executive
Job Location
Ranoli, Vadodara, Gujarat, India
Qualification
B.Pharma, M.Pharma or relevant M.Sc.
Required Experience
3–5 years in API manufacturing units
Application Mode
Email application
Job Description: Regulatory Affairs Executive
The Regulatory Affairs Executive will support the preparation, review and maintenance of regulatory documentation for pharmaceutical products, particularly in the active pharmaceutical ingredient (API) manufacturing sector. The role involves coordinating with internal departments, supporting submissions for international markets and maintaining accurate regulatory records.
The selected candidate will work with teams such as Research and Development (R&D), Quality Control (QC), Quality Assurance (QA) and Production to collect technical information and ensure that regulatory documentation is complete and appropriately maintained.
Roles and Responsibilities
Candidates applying for the Regulatory Affairs Executive position should be prepared to handle the following responsibilities:
- Support the preparation of regulatory documents, including Drug Master File (DMF) sections, Certificate of Pharmaceutical Product (CoPP), GMP documentation and Certificate of Suitability (CEP) documentation.
- Collect, compile and review technical and quality data from R&D, QC, QA and Production departments.
- Assist with regulatory submissions for international markets and track the status of applications and approvals.
- Maintain regulatory databases, filing records and documentation in an organised and accessible manner.
- Coordinate responses to regulatory deficiencies and queries.
- Support post-approval changes and help maintain updated regulatory documentation.
- Collaborate with cross-functional teams to obtain the information required for regulatory filings.
Educational Qualification
Applicants should hold one of the following qualifications:
- B.Pharma (Bachelor of Pharmacy).
- M.Pharma (Master of Pharmacy).
- M.Sc. in Pharmaceutical Regulatory Affairs, Organic Chemistry or a relevant discipline.
Candidates should have an educational background relevant to pharmaceutical manufacturing, regulatory documentation or related scientific fields.
Experience Requirements
Applicants should have 3–5 years of relevant experience in API manufacturing units.
Experience in preparing regulatory documents, handling technical and quality information, supporting international submissions and maintaining regulatory records will be relevant to this position.
Preference: Candidates with a Quality Control (QC) background will be preferred by the company.
Salary and Benefits
The company has not disclosed the official salary package or employee benefits in the supplied job notification. Compensation may depend on the candidate’s qualifications, relevant experience and current salary.
For planning purposes, an indicative market-based estimate for a professional with 3–5 years of relevant experience could be approximately ₹4 lakh–₹7 lakh per annum. This is an estimate only and is not a confirmed salary range from Asence Pharma.
Candidates can clarify the offered CTC, benefits, working arrangements and other employment terms with the recruitment team during the selection process.
How to Apply for Asence Pharma Recruitment
Eligible candidates interested in the Regulatory Affairs Executive vacancy can apply by following these steps:
- Prepare an updated CV highlighting relevant experience in API manufacturing and regulatory affairs.
- Include educational qualifications, previous employment details and experience with regulatory documentation.
- Mention relevant experience with DMF, CoPP, GMP, CEP documentation and international regulatory submissions, where applicable.
- Email the updated CV to the recruitment email address provided below.
Apply via Email
Send your updated CV to
hr@asence.com
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Suggested email subject: Application for Regulatory Affairs Executive – Vadodara
