The global CRO leader Syneos Health is hiring Regulatory Associates (EU Market – CMC Module 3) and Regulatory Affairs Associates (Mumbai). These roles are ideal for candidates with 0.5–2 years of experience in regulatory affairs, CMC documentation, and lifecycle management.
If you’re aiming to build a career in Regulatory Affairs, CMC Module 3, EU submissions, or drug registration, this opportunity offers strong exposure to IND, NDA, MAA, and global regulatory environments.
🔑 Key Job Highlights
- Role: Regulatory Associate / Regulatory Affairs Associate
- Company: Syneos Health
- Experience: 6 months – 2 years (internship accepted)
- Location: Remote / Gurugram (Hybrid) / Mumbai
- Industry: Clinical Research, Regulatory Affairs, CRO
- Employment Type: Full-Time
📌 Job Responsibilities
Regulatory Associate (EU CMC Module 3)
- Assist in preparation of CMC Module 3 documents for regulatory submissions
- Support IND, NDA, MAA, DMF, variations, renewals, and lifecycle management
- Perform gap analysis and regulatory intelligence research
- Conduct quality checks (QC) of submission documents
- Assist in orphan drug designation submissions
- Compile, analyze, and report regulatory data
Regulatory Affairs Associate (Mumbai)
- Manage drug registrations, renewals, variations, and import licenses
- Prepare regulatory documentation for tenders and submissions
- Maintain dossiers, artwork databases, and tracking tools
- Coordinate with cross-functional teams and global stakeholders
- Support labeling, lifecycle updates, and regulatory strategy planning
- Perform bibliographic and regulatory database searches
🎓 Qualifications & Skills
- Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field
- 0.5–2 years experience in regulatory affairs or internship
- Knowledge of CMC (Chemistry, Manufacturing & Controls) for small molecules
- Exposure to EU, GCC, APAC regulatory markets (preferred)
- Strong skills in:
- Microsoft Office
- Documentation & QC
- Regulatory writing
- Excellent communication, analytical, and time management skills
💼 Benefits of Working at Syneos Health
- Work on 95% of EMA-approved products & global submissions
- Exposure to international regulatory frameworks (EU, FDA, APAC)
- Strong career development & training programs
- Collaborative, inclusive, and high-performance work culture
- Opportunity to work with top pharmaceutical clients globally
🚀 Why This Role is Important
Regulatory Associate roles, especially in EU CMC Module 3, are critical for ensuring drug approval, compliance, and lifecycle management. This job offers hands-on exposure to global regulatory submissions, making it highly valuable for career growth in Regulatory Affairs and Clinical Development.
📥 How to Apply
Application Link For Regulatory Associate (EU CMC Module 3)
Application Link For Regulatory Affairs Associate (Mumbai)
