New Life Medicals is a trusted global supplier of Reference Listed Drugs (RLDs), Comparator Drugs, Biosimilars, and Orphan Drugs for clinical trials and named patient programs. With a strong presence in the US, EU, Canada, Australia, Japan, and Asia, we ensure high-quality, regulatory-compliant pharmaceuticals for advancing clinical research.
Our expertise includes:
✔ RLD & Comparator Drug Sourcing
✔ Biosimilars & Complex Generics
✔ REMS Programs & Global Exports
✔ Strategic Manufacturing Partnerships
📍 Locations: US, India, Ireland | 🌐 Website: www.newlifemedicals.com
📋 Job Title: Regulatory Affairs Officer – Exports Division
📍 Location: Ahmedabad, Gujarat, India
🕒 Employment Type: Full-time, On-site
✅ Key Responsibilities
- Prepare and submit regulatory dossiers for international markets.
- Ensure compliance with FDA, EMA, WHO, and other global regulatory bodies.
- Coordinate with suppliers, manufacturers, and regulatory agencies for approvals.
- Track changing regulations and update internal processes accordingly.
- Support export documentation, labeling, and compliance checks.
- Work closely with cross-functional teams (Quality, Supply Chain, Business Development).
🎯 Eligibility & Skills Required
- Education: Bachelor’s/Master’s in Pharmacy, Life Sciences, or Regulatory Affairs.
- Experience: 1-3 years in pharma regulatory affairs, exports, or compliance.
- Skills:
- Knowledge of CTD/eCTD, ICH guidelines, GMP, GDP.
- Familiarity with US FDA, EMA, ANVISA, TGA, and other regulatory pathways.
- Strong documentation & communication skills.
- Proficiency in MS Office & regulatory databases.
🌟 Why Join New Life Medicals?
✔ Global Exposure: Work with international pharma regulations.
✔ Career Growth: Opportunities in regulatory strategy & leadership.
✔ Impactful Role: Contribute to clinical trials & patient access programs.
✔ Competitive Salary & Benefits: As per industry standards.
📨 How to Apply
Interested candidates can send their resume & cover letter to:
📧 Email: hr@newlifemedicals.com
📌 Subject Line: “Application for Regulatory Affairs Officer – Exports”