Are you an experienced professional in international regulatory affairs with a passion for ensuring compliance in the pharmaceutical industry? Swiss Parenteral Limited, a leading name in parenteral products, is hiring for Executive to Assistant Manager roles in their Regulatory Affairs team, based in Sindhu Bhavan, Ahmedabad. This opportunity is perfect for candidates with expertise in CTD, ACTD, eCTD, and dossier preparation, targeting markets in Africa, LATAM, MENA, and APAC. Join a dynamic team and contribute to global regulatory compliance in the pharmaceutical sector.
Responsibilities
- Prepare and review CTD, ACTD, and eCTD dossiers for regulatory submissions in ROW markets (Africa, LATAM, MENA, APAC).
- Ensure compliance with international regulatory guidelines for parenteral products.
- Coordinate with cross-functional teams for dossier preparation and submission.
- Conduct dossier reviews to meet quality and regulatory standards.
- Stay updated on regulatory requirements across Africa, LATAM, MENA, and APAC markets.
- Support audits and provide documentation for regulatory approvals.
Qualifications
- Education: B.Pharm or M.Pharm from a recognized institution.
- Experience: 3-8 years in core regulatory affairs, with expertise in parenteral products.
- Skills: Proficiency in CTD, ACTD, eCTD, dossier preparation, and dossier review.
- Market Knowledge: Familiarity with regulatory frameworks in Africa, LATAM, MENA, and APAC.
- Note: Freshers are not eligible for this position.
Benefits
- Competitive salary in the range of INR 5,00,000 to 10,00,000 per annum, based on experience.
- Opportunity to work with a leading pharmaceutical company specializing in parenteral products.
- Professional growth in international regulatory affairs with exposure to global markets.
- Collaborative work environment in Sindhu Bhavan, Ahmedabad.
- Access to industry-leading tools and training for dossier preparation and compliance.
How to Apply
Interested candidates with 3-8 years of experience in regulatory affairs and parenteral products can send their CVs to hroffice1@swiss.in. Ensure your CV highlights your expertise in CTD, ACTD, eCTD, and dossier preparation. Applications from freshers will not be considered. Apply by November 04, 2025, to be part of Swiss Parenteral Limited’s mission to deliver high-quality pharmaceutical solutions globally.
FAQs
Q: What markets does this role focus on?
A: The role involves regulatory affairs for ROW markets, including Africa, LATAM, MENA, and APAC.
Q: What experience is required for this position?
A: Candidates need 3-8 years of experience in core regulatory affairs, specifically with parenteral products and expertise in CTD, ACTD, eCTD, and dossier preparation.
