Senior Regulatory CMC Lead - Small Molecule & Veeva RIM

Emploive; Toronto; Hybrid; CAD 120,000 - 180,000; Full time

Job summary

Syneos Health in Ontario, Toronto, is seeking a Manager/Senior Regulatory CMC Consultant for small molecule products and Veeva RIM. The role focuses on executing global regulatory CMC strategies, preparing CMC submissions, and guiding cross-functional teams to ensure global compliance across development and commercialization programs.

The candidate should possess strong knowledge of FDA, EMA, Health Canada, LATAM, Middle East, and ICH guidelines, with a track record in CMC submissions and

Qualifications

• Strong interpersonal skills to exchange complex information with others and to guide others.
• Proficiency in regulatory guidelines (FDA, EMA, Health Canada, ICH).
• Experience in the preparation, including writing, of CMC submissions.
• Strategic thinking and strong problem solving skills.
• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner.

Responsibilities

• Reviews CMC sections of regulatory submissions and interacts with regulatory agencies.
• Contributes to global regulatory CMC strategies for commercial products.
• Works with regulatory colleagues on development of global regulatory CMC strategies and submissions.
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders.
• Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.

Skills

Interpersonal skills

Regulatory guidelines

CMC submissions

Strategic thinking

Cross-functional collaboration

Planning & prioritization

Regulatory problem solving

Communication

Education

Bachelor's degree (life sciences)

Job description

Syneos Health in Ontario, Toronto, is seeking a Manager/Senior Regulatory CMC Consultant for small molecule products and Veeva RIM. The role focuses on executing global regulatory CMC strategies, preparing CMC submissions, and guiding cross-functional teams to ensure global compliance across development and commercialization programs.

The candidate should possess strong knowledge of FDA, EMA, Health Canada, LATAM, Middle East, and ICH guidelines, with a track record in CMC submissions and