Senior Regulatory CMC Consultant – Small Molecule & Veeva RIM

About the role

Syneos Health is seeking an experienced Manager/Senior Regulatory CMC Consultant to lead small‑molecule projects and drive Veeva RIM implementation across EMEA, LATAM and Canada. You will manage project teams, interact with regulatory authorities and provide strategic regulatory advice.

Key responsibilities

• Plan and execute regulatory submissions for INDs, product registrations and post‑approval activities in assigned regions.
• Manage day‑to‑day project teams, budgets, client invoicing and utilization tracking.
• Serve as the primary liaison with clients, regulatory agencies and internal departments.
• Lead regulatory research, write IND dossiers, clinical reports and other regulatory documents.
• Support business development, proposal creation and repeat‑business generation.

Required profile

• Proven experience managing regulatory CMC projects for small‑molecule products.
• Demonstrated line‑management experience, including hiring, performance management and staff development.
• Strong communication skills with ability to represent the regulatory function internally and externally.

Required skills

• Veeva RIM implementation and usage.
• Regulatory submission preparation (IND, product registration dossiers).
• Regulatory research and strategic advisory.