Syneos Health, a leading fully integrated biopharmaceutical solutions organization, is hiring for multiple Regulatory Affairs positions in Pune. If you have experience in CMC, pre/post-approval submissions, EU regulatory affairs, or portfolio management, this could be your next career opportunity.
🔍 Open Positions at Syneos Health Pune
1. Regulatory Associate (CMC – Pre and Post Approval)
Job ID: 25003845
Experience: Minimum 2 years
Qualifications: MS in Science/Healthcare or equivalent
Key Responsibilities:
- Assist in preparing regulatory submission documents (INDs, NDAs/MAAs, DMFs, variations, renewals).
- Conduct regulatory research for orphan drug designations.
- Perform quality checks on documents and support lifecycle maintenance activities.
2. Regulatory Associate
Job ID: 25003844-4
Experience: Minimum 2 years
Qualifications: MS in Science/Healthcare or equivalent
Key Responsibilities:
- Support preparation of regulatory documents for INDs, NDAs, MAAs, and lifecycle submissions.
- Conduct regulatory research and assist in quality control.
- Collaborate with cross-functional teams for compliance.
3. Senior Regulatory Associate (EU Market Experience, Module 1)
Job ID: 25003843
Experience: Minimum 3 years in EU regulatory affairs
Qualifications: BS/BA degree or equivalent
Key Responsibilities:
- Author Module 1 documents, cover letters, and application forms.
- Manage submissions in Veeva Vault, DMS, and RIMS.
- Conduct QC reviews and mentor junior associates.
4. Senior Regulatory Consultant (Portfolio Management, EU Market)
Job ID: 25003842
Experience: Minimum 5 years in EU regulatory portfolio management
Qualifications: BS/PhD in Science preferred
Key Responsibilities:
- Lead end-to-end regulatory strategy for EU submissions.
- Prepare CTD modules 1-4 and manage labeling processes.
- Represent Syneos Health in client meetings and regulatory discussions.
🏢 About Syneos Health
Syneos Health is a global biopharmaceutical solutions company with 29,000+ employees across 110 countries. They specialize in clinical development, medical affairs, and commercialization, accelerating therapies to market.
Why Join Syneos Health?
✅ Career growth & training programs
✅ Inclusive Total Self culture
✅ Work on cutting-edge regulatory projects
✅ Global exposure & collaborative environment
📥 How to Apply?
Application Link For Regulatory Associate (CMC – Pre and Post Approval)
Application Link For Regulatory Associate
Application Link For Senior Regulatory Associate (EU Market Experience, Module 1)
Application Link For Senior Regulatory Consultant (Portfolio Management, EU Market)
