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 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

As a senior leader and subjectmatter 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 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

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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 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.

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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 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 . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Accessibility Policy

AmerisourceBergen is committed to fair and accessible employment requested AmerisourceBergen will accommodate people with disabilities during the recruitment assessment and hiring processes and during employment.

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