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Swiss Parenterals Ltd., a leading pharmaceutical manufacturing company in India, is hiring Regulatory Affairs Executives for its Ahmedabad location. This opportunity is ideal for professionals with 2–10 years of experience in regulatory affairs and dossier submission for ROW and EU markets, especially those with parenteral product exposure.
Candidates with strong knowledge of CTD, ACTD, eCTD submissions, ICH guidelines, deficiency response preparation, and technical document review are encouraged to apply.
🔍 Job Overview
- Position: Regulatory Affairs Executive
- Company: Swiss Parenterals Ltd.
- Location: Sindhu Bhavan, Ahmedabad, Gujarat
- Experience Required: 2–10 Years
- Qualification: B.Pharm / M.Pharm
- Openings: 10
- Industry: Pharmaceutical / Healthcare
🧾 Key Responsibilities
- Compile and submit regulatory dossiers in CTD, ACTD, eCTD & country-specific formats
- Prepare and respond to regulatory queries / deficiency letters / notices of deficiency
- Coordinate with QC, QA, and Production for regulatory documentation
- Manage license renewals, variations, updates, and re-registrations
- Maintain regulatory databases, tracking systems, and product chronologies
- Compile technical dossiers for tender participation
- Review BMR, stability protocols & reports, specifications, and validation documents
- Initiate and review artworks, labels, SmPC, package inserts, cartons & foils
- Ensure compliance with ICH and country-specific guidelines
- Support RA Head and handle team reporting activities
🎓 Qualifications & Skills
- B.Pharm or M.Pharm degree
- 2–10 years of hands-on experience in Regulatory Affairs
- Proven experience in ROW & EU dossier submission
- Strong understanding of ICH guidelines
- Excellent deficiency response preparation skills
- Experience with parenteral formulations mandatory
- Good communication and documentation skills
💰 Salary & Benefits
- Salary Range: ₹4,00,000 – ₹8,00,000 per annum (as per experience & interview)
- Opportunity to work with an established pharma organization
- Career growth in global regulatory operations
- Professional learning environment
📩 How to Apply
Interested and eligible candidates may send their updated CV to:
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Email: hroffice1@swiss.in
Website: www.swiss.in
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