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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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
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Kyiv |Lima Region :
Lima |France :
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