Partner with the management team to help direct and support the business
Lead and manage all CMC regulatory activities for biologics programs across the product lifecycle
Oversee CMC components of regulatory submissions, including CTAs, INDs, NDSs, NDAs, BLAs, and NSNs
Act as the CMC regulatory SME, advising project teams on strategy, risk, and key decision points
Support and participate in health authority interactions and agency meetings
Manage post‑approval changes and lifecycle management activities
Partner with internal teams, CROs, CMOs, clients, and regulatory agencies to deliver high‑quality outcomes
Serve as a trusted client contact, supporting scoping, quoting, deliverable review, and invoice reconciliation
Manage key client accounts to ensure deliverables, timelines, and expectations are met
Lead multiple projects simultaneously, prioritizing effectively to meet tight timelines and budgets
Stay current with evolving global regulations and guidance to provide up‑to‑date regulatory advice
Lead, mentor, and develop team members through clear delegation, coaching, and planning
Maintain and contribute to internal SOPs and job aids

Post‑secondary degree in biological, pharmaceutical, chemical, engineering sciences, or a related field
10–15 years of direct CMC Regulatory Affairs experience, with a strong focus on biologics
Hands‑on experience authoring and/or reviewing Module 3, and leading or supporting health authority interactions
Proven leadership experience and/or regulatory consulting background
Direct experience with a range of submission types, including: Writing/reviewing Module 3 and Module 2.3 for CTAs, INDs, NDSs, NDAs, and BLAs
Drug substance and drug product CMC sections
Control strategy, specifications, stability, analytical methods, validation, comparability, and viral safety
Strong understanding of Health Canada and FDA CMC regulatory requirements
Knowledge of Environment Canada New Substances Regulations

Director, Regulatory Affairs CMC – Biologics

Key skills