Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, accelerating customer success through clinical, medical affairs, and commercial insights. With 29,000+ employees across 110 countries, Syneos Health is dedicated to simplifying drug development and improving patient outcomes.
Why Join Syneos Health?
✅ Career Growth: Training, mentorship, and global opportunities.
✅ Flexible Work: Homebased or hybrid options (Gurugram).
✅ Inclusive Culture: Embraces diversity and Total Self values.
✅ Impactful Work: Contributes to 94% of Novel FDA Approvals and 95% of EMA Authorized Products.
Job Description: Regulatory Associate (EU Market) – Homebased
Key Responsibilities:
- Prepare and review global CMC dossiers, variations, and post-approval changes for EU, US, LATAM, APAC, and other markets.
- Assist in regulatory submissions (INDs, NDAs/MAAs, DMFs, renewals, MATs).
- Conduct regulatory research for orphan drug designations and compliance.
- Perform quality checks on regulatory documents.
- Collaborate with cross-functional teams to ensure timely and compliant submissions.
- Maintain up-to-date knowledge of EU and global regulatory guidelines.
Eligibility & Skills Required:
- Education: M.Pharma (Preferred) or M.Sc in Life Sciences/Healthcare.
- Experience: 1+ years in Global Regulatory Affairs (CMC focus preferred).
- Technical Skills: Advanced Microsoft Office, regulatory databases.
- Soft Skills: Strong analytical, communication, and project management abilities.
- Language: Fluent in English (written & spoken).
- Preferred: Internship experience in Regulatory Affairs (CMC).
Benefits & Perks
- Work Flexibility: Fully remote or hybrid (Gurugram).
- Learning & Development: Regulatory training, career progression.
- Global Exposure: Work with international teams & clients.
- Competitive Compensation: Attractive salary & benefits.
- Inclusive Culture: Supportive, diverse, and engaging workplace.
How to Apply
- Job ID: 25100207
- Locations: Remote (India) / Hybrid (Gurugram)
