Mgr/Sr 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 guide regulatory strategy, manage project teams and serve as the primary liaison with clients and authorities.

Key responsibilities

• Plan and execute regulatory submissions for INDs, product registrations and post‑approval activities in assigned regions.
• Lead day‑to‑day project management, including budgeting, invoicing, utilization tracking and team performance.
• Provide regulatory advice, conduct research, and prepare IND dossiers, clinical reports and other regulatory documents.
• Represent the regulatory department with internal functions and external agencies, and support business development efforts.

Required profile

• Extensive experience in CMC regulatory affairs for small‑molecule products.
• Proven line‑management skills, including hiring, performance management and staff development.
• Ability to travel up to 25% of the time and work remotely.

Required skills

• Veeva RIM implementation and usage.
• Regulatory submission preparation (IND, product registration dossiers).
• Project budgeting and financial oversight.