Job Title

Director, Regulatory Affairs CMC Biologics 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 crossfunctional 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 postapproval lifecycle management. What Youll Do 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 postapproval changes and lifecycle management activities Partner with internal teams, CROs, CMOs, clients, and regulatory agencies to deliver highquality 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 uptodate 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 Postsecondary degree in biological, pharmaceutical, chemical, engineering sciences, or a related field 1015 years of direct CMC Regulatory Affairs experience, with a strong focus on biologics Handson 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 problemsolving ability for complex regulatory issues Comfortable leading in a crossfunctional, multidisciplinary environment Highly organized, detailoriented, and dependable with deadlines Excellent written and verbal communication skills Strong presentation and stakeholdermanagement 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, sciencedriven teams and global clients Balance handson regulatory work with client engagement and team leadership What Cencora offers 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, including backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. We also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and more. Salary Range $135,200 CAD - $208,340 CAD Affiliated Companies Innomar Strategies Equal Employment Opportunity 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 companys 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 nondiscriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. Accessibility Policy 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. #J-18808-Ljbffr