We're seeking a Director, Regulatory Affairs CMC – Biologics to provide strategic and operational regulatory leadership across the biologics product lifecycle.

The Director/Consultant, Regulatory CMC-Biologics will report into the Director, Regulatory Affairs-CMC. They will be responsible for leading and managing all CMC Regulatory files and will have overall responsibility for CMC aspects of regulatory submissions (e.g. CTAs, INDs, NDSs, NDAs, BLAs, NSNs), regulatory assessments, post-approval change management, agency meetings and consulting services.

They will lead, participate in and support project team(s) with CMC regulatory updates and strategies as applicable. They will manage other related duties as assigned.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Participate as a member of the management team to direct and manage the affairs of the company
• Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients/CMOs/agencies
• Act as primary contact for clients with responsibility for maintaining client relationships, including quoting, invoice reconciliation and performing/reviewing client work
• Responsible for the overall management of key accounts, once acquired, to ensure compliance with client internal review process and all required external approvals
• Develop and maintain partnerships with senior decision-makers within all departments to effectively achieve business results
• Facilitates the preparation and review of complex regulatory packages to ensure effective data presentation and quality scientific data in alignment with Canadian and US regulatory requirements for biologic and pharmaceutical clients
• Acts as CMC regulatory expert for product task force and is accountable for recommending CMC regulatory strategy for various products with a focus on biologics, from development through commercialization
• Effectively prioritize, coordinate and complete multiple projects within established timeframes
• Overall responsibility for CMC aspects of regulatory submissions (e.g. CTAs, INDs NDSs, NDAs, BLAs,), regulatory assessments, agency meetings, new substance notifications and consulting services
• Effective intercompany communication skills for lifecycle management of a product(s).
• Project Management to ensure that assigned projects meet client budget, quoted timelines, maintain company goals and client expectations
• Maintain professional and up to date regulatory knowledge in order to provide effective consulting advice
• Develop and manage regulatory team members, including but not limited to assignment of delegation, time and budget management, skill and knowledge
• Maintain relevant internal job aids/SOPs Other related duties as assigned

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• B.Sc. / M.Sc. degree in life sciences (Pharmacology, Molecular Biology, Biology, Chemistry or Pharmacy)
• 10-15 years direct CMC experience in Regulatory Affairs experience with a clear focus on biologics, including authoring/reviewing Module 3 and leading health authority interactions for biologic programs
• Leadership skills and/or consulting experience

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

• Effective project and people management skills including the ability to complete multiple projects within established client and agency timelines
• Demonstrate strategic planning and problem-solving skills to determine innovative solutions to complex issues
• Demonstrate leadership abilities in a cross-functional, multi-disciplinary team environment
• Direct experience and working knowledge of a wide range of regulatory submissions types including:
  • Experienced in writing and reviewing Module 3 and Module 2.3 sections for CTAs/INDs NDSs/NDAs/BLAs (e.g., drug substance/drug product, control strategy, specifications, stability, analytical methods, validation, comparability, viral safety).
  • Knowledge and experience of Environment Canada New Substance Regulations
• Understanding of Health Canada and FDA regulations and guidance’s related to the CMC regulatory landscape
• Strong analytical and mathematical skills
• Ability to communicate effectively both orally and in writing in a timely manner
• Effective interpersonal and leadership skills
• Effective organizational skills; attention to detail
• Ability to consistently meet deadlines
• Excellent problem-solving skills; ability to resolve issues effectively and efficiently
• Excellent presentation skills
• Proficient with Microsoft Word, Excel, PowerPoint and other Office Programs

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. 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

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 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

Accessibility Policy

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

As per ESA legislation, this role is excluded from pay transparency requirements in Ontario RECRUITING FOR THE FUTURE. This posting is for a future job opportunity. If you don't see anything posted that interests you right now, submit your resume and we can keep you in mind for future French-English bilingual opportunities. Please note that only those who qualify will be contacted.

Affiliated Companies:

Affiliated Companies: Innomar Strategies