Director, Regulatory Affairs CMC - Biologics

Cencora•Springfield, ON

6d•Onsite

About The Position

We are seeking an experienced Director, Regulatory Affairs CMC – Biologics to provide strategic and operational regulatory leadership across the biologics product lifecycle. This role is ideal for a senior regulatory professional who enjoys leading complex CMC submissions, advising clients, and partnering closely with cross‑functional teams. Reporting to the Director, Regulatory Affairs – CMC, you will have overall responsibility for CMC aspects of regulatory submissions, regulatory strategy, health authority interactions, and post‑approval lifecycle management.

Requirements

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
Strong project and people leadership skills
Strategic thinker with practical problem‑solving ability for complex regulatory issues
Comfortable leading in a cross‑functional, multidisciplinary environment
Highly organized, detail‑oriented, and dependable with deadlines
Excellent written and verbal communication skills
Strong presentation and stakeholder‑management skills
Proficiency with Microsoft Word, Excel, PowerPoint, and other Office tools

Responsibilities

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