Advertisement
AMN Life Science Pvt. Ltd., a leading EU-GMP pharmaceutical manufacturer specializing in 100% export-focused OSD formulations, is hiring a talented Regulatory Affairs Executive in Mumbai.
This role is ideal for candidates with 1–3 years of RA experience, strong knowledge of CTD/ACTD filings, and exposure to global regulatory frameworks, including FDA, EMA, TGA, Health Canada, and ROW markets.
If you are looking to advance your career in pharma regulatory affairs in Mumbai, this opportunity offers excellent exposure, cross-functional collaboration, and a competitive salary.
🚀 Key Responsibilities
1. Regulatory Submissions
- Prepare and submit CTD/ACTD dossiers to global health authorities (MOH-ROW, FDA, EMA, etc.).
- Ensure accuracy, completeness, and compliance during submissions.
2. Regulatory Strategy
- Develop regulatory pathways for new and existing OSD products.
- Work closely with R&D, QA, Production, Clinical, and Legal teams.
3. Compliance & Documentation
- Monitor regional regulatory requirements (EMA, Health Canada, TGA, ROW).
- Maintain updated regulatory documentation and SOPs.
4. Regulatory Intelligence
- Track global regulation updates, trends, and compliance changes.
- Guide internal teams to meet evolving regulatory expectations.
5. Labeling & Artwork Review
- Evaluate product labels, artworks, and marketing claims for regulatory compliance.
6. Regulatory Communication
- Act as the primary contact for regulatory bodies.
- Manage queries, clarifications, and approval communications.
7. Risk Management
- Conduct regulatory risk assessments and propose mitigation strategies.
8. Training & Support
- Support teams during audits and inspections.
- Train cross-functional stakeholders on regulatory processes.
🎓 Qualifications & Skills Required
- Education: B.Pharm / M.Pharm / Regulatory Affairs Certification
- Experience: 1–3 years in Pharma Regulatory Affairs (OSD preferred)
- Strong knowledge of FDA, EMA, ICH, ROW guidelines
- Excellent written and verbal communication
- Hands-on experience with eCTD, regulatory tracking systems
- Strong attention to detail and project management skills
- Ability to multitask and coordinate with cross-functional teams
💼 Salary & Benefits
- Salary Range: ₹4.5–5.5 LPA
- Exposure to EU-GMP manufacturing
- Work with diverse global markets
- Skill growth in regulatory strategy, submissions & global compliance
- On-site role ensures strong collaboration and visibility
📍 Job Location
Kurla, Mumbai, Maharashtra (On-site)
Advertisement
📧 How to Apply
Interested candidates can apply by contacting the recruiter and sending their updated CV:
Call / WhatsApp: +91 8976869261
Email:
Advertisement
