Syneos Health®, a global biopharmaceutical solutions leader, is hiring a Senior Regulatory Associate (EU Market Experience) for its India operations. This is an excellent opportunity for regulatory affairs professionals with hands-on experience in EU regulatory submissions, post-approval variations, and CTD/eCTD authoring to work in a remote or hybrid (Gurugram) model.
With exposure to EMA-authorized products, global lifecycle management, and cross-regional regulatory markets (EU, APAC, Gulf), this role is ideal for candidates looking to advance their regulatory affairs career in a top global CRO.
🧪 Key Job Details
- Job Title: Senior Regulatory Associate (EU Market Experience)
- Company: Syneos Health®
- Job Type: Full-time
- Work Model: Remote (India) / Hybrid (Gurugram)
- Experience Required: 2–3+ years
- Job ID: 25105062
- Posted On: January 29, 2026
📌 Job Responsibilities – Regulatory Affairs (EU Market)
As a Senior Regulatory Associate, you will support non-complex to moderately complex regulatory submissions across global markets, with a primary focus on the EU regulatory framework.
Core Responsibilities:
- Prepare and submit EU Marketing Authorisation Applications (MAA) and post-approval variations
- Support regulatory lifecycle management activities across EU, APAC, and Gulf markets
- Author and review CTD Modules 2 & 3
- Ensure submissions comply with EMA and global regulatory guidelines
- Maintain and update regulatory databases, trackers, and logs
- Perform quality control (QC) reviews of regulatory documents
- Coordinate with project managers, senior regulatory staff, and clients
- Identify regulatory risks and escalate issues proactively
- Mentor and support junior regulatory associates
- Participate in client meetings and contribute to long-term client relationships
- Maintain training records and complete all mandatory compliance training
🎓 Qualifications & Skills Required
Educational Qualifications:
- BS/BA degree in Pharmacy, Life Sciences, or equivalent practical experience
(B.Pharm / M.Pharm candidates strongly preferred)
Experience & Skills:
- 2–3+ years of EU regulatory affairs experience
- Hands-on experience with:
- Initial MAA submissions
- Post-approval variations
- CTD / eCTD authoring
- Strong knowledge of EU regulatory requirements
- Excellent written and verbal English communication skills
- Proficiency in Microsoft Office tools
- Strong analytical and organizational skills
- Ability to manage multiple regulatory projects simultaneously
- Experience working independently in a global regulatory environment
💼 Why Join Syneos Health?
Syneos Health offers a career-driven, inclusive, and globally connected work environment.
Employee Benefits:
- Global exposure to EMA-authorized and FDA-approved products
- Remote and hybrid work flexibility
- Structured career development and regulatory training
- Supportive leadership and mentoring culture
- Competitive compensation and total rewards program
- Inclusive Total Self culture promoting diversity and belonging
Over the last 5 years, Syneos Health has supported:
- 95% of EMA-authorized products
- 94% of novel FDA-approved drugs
- 675,000+ clinical trial patients worldwide
📝 How to Apply
