Advertisement
Swiss Parenterals Limited is hiring an experienced Regulatory Affairs – API Officer/Executive for its Ahmedabad location. This is an excellent career opportunity for RA professionals skilled in DMF preparation, ICH guidelines, genotoxic risk evaluation, and API dossier submissions for global markets. If you have 3–5 years of hands-on experience in Regulatory Affairs for APIs, this role offers career stability, global exposure, and a growth-driven work environment.
Key Responsibilities
- Prepare, compile, and review DMFs for EU, Brazil, Canada, and ROW markets.
- Apply strong knowledge of ICH Q-series and ICH M7 (genotoxic impurity assessment, including nitrosamine evaluation).
- Develop and compile dossiers related to 3.2.S (for APIs) and 2.3.S sections.
- Prepare accurate and timely responses to Ministry of Health (MoH) queries.
- Collaborate with cross-functional teams to ensure regulatory compliance and documentation accuracy.
Required Qualifications
- Education: B.Pharm / M.Pharm
- Experience: 3–5 years in Regulatory Affairs – API (No freshers)
- Expertise in:
- API DMF compilation and review
- ICH Q guidelines, ICH M7
- Nitrosamine impurity assessment
- Dossier submissions for regulated/semi-regulated markets
- Responding to global regulatory authority queries
Location
📍 Sindhu Bhavan, Ahmedabad, Gujarat
Benefits of Working with Swiss Parenterals Limited
- Opportunity to work on global regulatory submissions
- Exposure to international markets and guidelines
- Professional growth in a reputed pharmaceutical organization
- Competitive industry-standard salary package
How to Apply
Interested and eligible candidates may email their updated CV to:
📩 hroffice1@swiss.in