Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With a workforce of 29,000+ employees across 110 countries, Syneos Health combines clinical, medical affairs, and commercial expertise to address modern market challenges.
The company fosters a Total Self culture, promoting diversity, inclusion, and career growth. Recognized for its agility and innovation, Syneos Health has contributed to 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products over the past five years.
🔗 Learn more: www.syneoshealth.com
Job Description: Regulatory Associate (CMC)
Primary Responsibilities:
✔ Preparation of high-quality global CMC dossiers for variations, renewals, annual reports, and lifecycle maintenance.
✔ Post-approval variation experience (EU Market) is mandatory; pre-approval MAA dossier experience (ROW markets) is preferred.
✔ Ensure compliance with ICH, FDA, EMA, and other global regulatory guidelines.
✔ Support Annual Product Quality Review (APQR) and regulatory submissions (IND, NDA, MAA, CTD).
✔ Liaise with cross-functional teams to gather documentation for submissions.
✔ Track and submit regulatory commitments, ensuring adherence to timelines.
✔ Use RIMS/Veeva Vault for regulatory information management (preferred).
Secondary Responsibilities:
✔ Understanding ROW (LATAM, APAC, Middle East, Africa, China) regulatory requirements.
✔ Support in change control assessments and response to Health Authority queries.
✔ Work in cross-cultural/virtual teams with strong communication skills.
Qualifications & Skills:
✅ Master’s degree in Pharmaceutical Sciences (preferred) or Life Sciences.
✅ Minimum 1 year of experience in CMC regulatory affairs (post-approval variations for EU required).
✅ Experience in eCTD submissions, regulatory compliance, and dossier preparation.
✅ Strong Microsoft Office skills (Word, Excel, PowerPoint).
✅ Excellent written & verbal communication in English.
✅ Ability to multi-task, prioritize, and meet deadlines in a fast-paced environment.
Why Join Syneos Health?
🌟 Career Growth: Continuous learning, mentorship, and global exposure.
🌟 Inclusive Culture: Emphasis on diversity, work-life balance, and employee well-being.
🌟 Impactful Work: Contribute to life-changing therapies and global drug development.
