Aculife Healthcare Pvt. Ltd., part of the esteemed Nirma Group, is hiring Regulatory Affairs professionals at its Ahmedabad Head Office. This is a golden opportunity for candidates with hands-on experience in international regulatory submissions (LATAM, Brazil, Mexico, and EU markets) to advance their careers in one of India’s leading pharmaceutical companies.
If you have 6 months to 2 years of core IRA (International Regulatory Affairs) experience and aspire to grow in a dynamic and globally compliant environment, this role is for you.
🧾 Job Details
Position: Regulatory Affairs Executive / Officer
Location: Ahmedabad, Gujarat (Head Office)
Company: Aculife Healthcare Pvt. Ltd. (Nirma Group)
Compensation: Best in the industry
Employment Type: Full-time
🧩 Key Responsibilities
- Compile and review registration dossiers as per country-specific guidelines.
- Manage LATAM region submissions (Brazil, Mexico) and work on EU market dossiers.
- Handle submission management systems for regulatory filings.
- Review key technical documents including:
- DMF, Product Development Reports, BMR, BPR
- Analytical Method Validation Reports, Specifications, STP, Stability Reports, BE Study Reports
- Prepare and respond to regulatory deficiency queries.
- Manage post-approval variations and ensure compliance with global regulatory standards.
- Coordinate with overseas regulatory teams, agents, and distributors to ensure timely dossier submissions.
- Review artworks and packaging materials for ongoing and new product launches.
- Maintain registration databases and ensure updates in the central repository.
🎓 Preferred Candidate Profile
- Qualification: M.Pharm / B.Pharm / M.Sc. (Life Sciences preferred).
- Experience: 6 months – 2 years in International Regulatory Affairs.
- Strong understanding of regulatory guidelines for LATAM and EU markets.
- Excellent technical documentation and communication skills.
- Proficiency in dossier compilation, variation submission, and coordination with regulatory authorities.
💼 Why Join Aculife Healthcare?
- Work with one of India’s top pharma companies under the Nirma Group.
- Exposure to global markets (EU, LATAM, Brazil, Mexico).
- Competitive compensation and career development opportunities.
- Collaborative and learning-oriented work environment.
📧 How to Apply
Interested and eligible candidates can send their updated resume to:
📩 satabdeerath@aculife.co.in
Use the subject line: Application for Regulatory Affairs – Ahmedabad
