Emcure Pharmaceuticals is hiring an Executive – Regulatory Affairs in Ahmedabad for professionals with 3 to 8 years of experience in regulatory affairs and an M.Pharm qualification. Candidates with strong EU and UK regulatory market experience and hands-on knowledge of regulatory submissions, eCTD, ICH guidelines, post-approval variations and health authority queries are encouraged to apply.
Job Title: Executive – Regulatory Affairs
Company: Emcure Pharmaceuticals
Location: Ahmedabad, Gujarat
Experience: 3–8 Years
Qualification: M.Pharm
Industry: Pharmaceutical / Regulatory Affairs
Employment Type: Full Time
Market Experience: EU & UK Regulatory Markets
Author: Pharmabharat Editorial Team
Executive – Regulatory Affairs Job Responsibilities
The selected candidate will support regulatory activities for international markets, with particular emphasis on European Union (EU) and United Kingdom (UK) regulatory submissions.
Key responsibilities include:
- Manage and support regulatory activities for EU and UK markets.
- Support authoring and preparation of eCTD Modules 1–5.
- Work on post-approval variations and related regulatory submissions.
- Support initial marketing authorisation applications (MAAs).
- Prepare, compile and review regulatory documentation.
- Support responses to health authority queries.
- Ensure regulatory documents are prepared according to applicable requirements and submission standards.
- Apply knowledge of relevant ICH guidelines to regulatory documentation and submissions.
- Coordinate with cross-functional teams to collect and review required submission documents.
- Perform quality checks and ensure regulatory dossiers are complete, accurate and submission-ready.
- Support regulatory document compilation and publishing activities.
- Maintain awareness of applicable EU and UK regulatory requirements and changes.
Eligibility Criteria
Candidates applying for the Executive – Regulatory Affairs job in Ahmedabad should meet the following requirements:
Educational Qualification
- M.Pharm is required.
Experience
- 3 to 8 years of relevant experience in Regulatory Affairs.
- Experience with EU and UK regulatory markets is mandatory.
- Experience supporting pharmaceutical regulatory submissions is essential.
- Experience with Modules 1–5 is required.
Preferred Regulatory Affairs Skills
Candidates should have practical knowledge of:
- EU regulatory affairs
- UK regulatory affairs
- eCTD submissions
- Modules 1–5
- Post-approval variations
- Marketing authorisation applications
- Health authority queries
- Regulatory document compilation
- Regulatory document review
- ICH guidelines
- Pharmaceutical regulatory submissions
Experience with initial marketing authorisation applications will be an added advantage.
Why This Regulatory Affairs Opportunity Is Important
Regulatory Affairs professionals with EU and UK market experience are responsible for helping pharmaceutical companies navigate complex regulatory requirements and maintain compliant product registrations.
This opportunity is particularly relevant for professionals who have already worked on eCTD dossiers, post-approval variations, health authority responses and regulatory document review and want to further develop their international regulatory affairs career.
Executive – Regulatory Affairs Salary
The employer has not specified the salary in the supplied job description. Based on the experience requirement, a market-estimated range of approximately ₹5–10 LPA may be considered for SEO/schema purposes, but candidates should confirm the actual compensation with the employer during the recruitment process.
Current CTC and Expected CTC: Candidates are specifically requested to provide these details with their updated CV.
Job Location
Ahmedabad, Gujarat, India
This is a location-based opportunity for professionals seeking Regulatory Affairs jobs in Ahmedabad with experience in international pharmaceutical markets.
How to Apply
Interested candidates should send their updated CV/resume along with their current CTC and expected CTC to:
Email: bhavik.parekh@emcure.com