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Director/Consultant, Regulatory Affairs

12+ years
CAD 110,000 – 140,000 annually
10 May 23, 2025
Job Description
Job Type: Full Time Education: B.Sc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director/Consultant, Regulatory Affairs
Location: Remote, Ontario, Canada
Category: Quality
Job Type: Full time
Posted Date: May 5th 2025
Job ID: R257990

About Cencora
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details
Primary Duties and Responsibilities:

  • Prepare client proposals and generate new business for TPIreg, including leading presentations to potential Regulatory Affairs (RA) clients and participating in multifunctional presentations

  • Prioritize and manage multiple simultaneous projects to meet budgets (including invoice review), timelines, and client expectations; anticipate and resolve emerging issues

  • Develop and implement RA activities such as assessments, strategies, submissions, and agency interactions, applying expert knowledge in core regulatory areas (e.g., CMC, Medical Devices, CTAs, US regulations) and basic knowledge outside core areas

  • Maintain target billables by obtaining new business

  • Create opportunities to build agency relationships by participating in professional activities such as industry training, conference presentations, publications, and webinars

  • Lead client and agency interface, strengthening relationships and growing the business; ensure quality of deliverables through compliance with review and approval processes; identify and implement process improvements

  • Develop and maintain partnerships with senior decision-makers to build the business, resolve significant issues, and create opportunities

  • Analyze data, regulatory environment, and business objectives to make and implement recommendations; identify innovative solutions while managing uncertainty

  • Lead and advise clients and cross-functional teams on agency interactions

  • Lead decision-making and conflict resolution on regulatory issues within cross-functional teams

  • Proactively identify, share, and interpret regulatory intelligence

  • Manage multiple simultaneous projects to ensure on-budget delivery, timeline adherence, and client satisfaction

  • Engage in continuous learning to provide effective consulting and be a sought-after resource

  • Develop and manage 0-2 direct regulatory reports (Manager level or below), including delegation, time/budget management, and skill development

  • Travel as required

  • Perform other related duties as assigned

Experience and Educational Requirements:

  • B.Sc. degree in life sciences (Pharmacology, Molecular Biology, Biology, Chemistry, or Pharmacy) or Engineering

  • Advanced degree in related field preferred

  • 12+ years of relevant regulatory affairs or related experience in pharmaceutical/biologic/medical device development or manufacturing

  • In-depth experience in a designated area of specialization (e.g., Medical Devices, Clinical Trials, CMC) may be required

  • Regulatory Affairs Certification (RAC) and other certifications are assets

  • Prior consulting experience preferred

  • Demonstrated leadership skills

Minimum Skills, Knowledge, and Ability Requirements:

  • Broad understanding of international regulations, processes, and issues in drug/biologics/medical device development, including ICH, Health Canada, FDA, EMA, etc., with focus in area of specialization

  • In-depth experience managing Health Authority interactions regionally

  • Extensive regulatory expertise in specialization area (e.g., medical devices, CMC, advertising/promotion)

  • Wide knowledge of various regulatory submission types

  • Superior project management skills for multiple concurrent projects in dynamic environments

  • Advanced strategic planning and complex problem-solving skills to resolve issues efficiently

  • Senior leadership abilities in cross-functional, multi-disciplinary teams

  • Ability to drive results in team settings

  • Strong business and financial acumen

  • Strong analytical and mathematical skills

  • Effective oral and written communication skills

  • Excellent presentation, leadership, and interpersonal skills

  • Strong organizational skills and attention to detail

  • Consistent ability to meet deadlines

  • Proficient with Adobe Acrobat, Microsoft Word, Excel, and Outlook

  • Ability to build professional networks for business development and regulatory intelligence

What Cencora offers
We provide compensation, benefits, and resources to enable a highly inclusive culture and support our team members’ ability to live with purpose every day. Our comprehensive benefits include medical, dental, vision care, backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental and caregiver leave, and more. We also offer training programs, professional development resources, mentorship programs, employee resource groups, and volunteer opportunities.

Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to protected categories under federal, state, or local law. Harassment is prohibited, and all employment practices comply with non-discriminatory principles. Reasonable accommodations are available during employment processes for qualified individuals with disabilities.

Affiliated Companies: Innomar Strategies

Salary Range: Not specified; estimated CAD 110,000 – 140,000 annually based on role and location


 

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