Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, accelerating customer success by translating clinical, medical affairs, and commercial insights into actionable outcomes. With 29,000 employees across 110 countries, Syneos Health supports drug development from clinical trials to commercialization.
The company is known for its agile, patient-centric approach, fostering a collaborative “Total Self” culture that values diversity, inclusion, and career growth.
Job Description
Job Summary
The Regulatory Consultant will provide CMC regulatory support for EU-market projects, including submissions, post-approval variations, and lifecycle management. The role involves working with cross-functional teams, ensuring compliance with EU regulatory requirements, and supporting clients in drug development and approvals.
Key Responsibilities
✔ Author and review Module 3 (CMC) for regulatory submissions.
✔ Manage post-approval CMC variations and lifecycle maintenance.
✔ Provide EU regulatory expertise for submissions (MAA, CTD, variations).
✔ Use RIMS/Veeva Vault for regulatory documentation and troubleshooting.
✔ Prepare gap analyses, briefing documents, and regulatory strategies.
✔ Support client meetings, audits, and business development.
✔ Ensure compliance with global regulatory standards and company SOPs.
✔ Mentor junior team members and contribute to process improvements.
Eligibility & Qualifications
✅ Education: BS/PhD in a science-related field (Pharma, Chemistry, Biology).
✅ Experience: 6+ years in regulatory CMC (Module 3), EU market experience required.
✅ Technical Skills:
- Hands-on experience with RIMS/Veeva Vault.
- Knowledge of IND, NDA, MAA, CTD submissions.
- Strong Microsoft Office (Word, Excel, PowerPoint) skills.
✅ Soft Skills: - Excellent written & verbal communication (English fluency).
- Strong project management & problem-solving abilities.
- Ability to work independently & in a team.
Benefits & Culture
🌟 Career Growth: Training, mentorship, and progression opportunities.
🌟 Work-Life Balance: Remote work flexibility.
🌟 Inclusive Culture: “Total Self” environment promoting diversity.
🌟 Global Impact: Work on 94% of Novel FDA-Approved Drugs & 95% of EMA-Authorized Products.
