Teams at Syneos Health

Supports global regulatory CMC strategies for small-molecule development and marketed products. Reviews CMC sections of regulatory submissions, contributes to agency responses, prepares submission content, and advises cross-functional teams on global regulatory requirements. Provides guidance on product compliance topics, including change controls, deviations, and GMP investigations. Requires knowledge of FDA, EMA, Health Canada, LATAM, Middle East, and ICH guidelines, along with strong strategic, communication, planning, and problem-solving skills.

Oversees clinical trial site management, monitoring deliverables, risk mitigation, compliance, data integrity, study tools, training, resourcing, and clinical team performance. Coordinates with investigators, CRAs, central monitors, clients, project managers, and cross-functional teams to meet enrollment, database lock, quality, budget, and timeline objectives. Reviews monitoring documentation, supports inspection readiness, and escalates risks related to protocol execution and patient safety.

Supports Health Canada life-cycle submissions for biologic and small-molecule rare disease products. Responsibilities include Level III and sNDS submissions, Module 3 updates, PQRs, annual drug notifications, Clarifax responses, CMC authoring, direct Health Canada interaction, and Canadian regulatory intelligence. The consultant must work independently and provide regulatory support for Canadian submissions.