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Director, Regulatory Affairs CMC – Biologics
About the Role
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.
What You’ll Do
As a senior leader and subject‑matter expert, you will:
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
What You Bring:
Education & Experience
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
Technical Expertise
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
Skills & Strengths
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
Why Join Us
Work on innovative biologics programs across the full product lifecycle
Play a visible leadership role with real strategic impact
Collaborate with experienced, science‑driven teams and global clients
Balance hands‑on regulatory work with client engagement and team leadership
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We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.
Full time.
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
AmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.
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