Director, Regulatory Affairs CMC – Biologics
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full-time
Posted on:
Location Type: Remote
Location: Canada
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Salary
💰 CA$135,200 - CA$208,340 per year
Job Level
About the role
- Provide strategic and operational regulatory leadership across the biologics product lifecycle
- 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
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
Benefits
- medical, dental, and vision care
- backup dependent care
- adoption assistance
- infertility coverage
- family building support
- behavioral health solutions
- paid parental leave
- paid caregiver leave
- training programs
- professional development resources
- opportunities to participate in mentorship programs
- employee resource groups
- volunteer activities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CMC regulatory activitiesregulatory submissionsModule 3 authoringModule 2.3 authoringdrug substance CMCdrug product CMCcontrol strategyanalytical methodsvalidationviral safety
Soft Skills
leadershipmentoringcoachingproject managementcommunicationstrategic thinkingrisk managementclient managementteam collaborationprioritization