Director/Consultant, Regulatory Affairs

Cencora, Inc.; Ontario; On-site; CAD 90,000 - 150,000; Full time

Job summary

Join an innovative company dedicated to improving health outcomes for people and animals. This role offers the opportunity to lead regulatory affairs projects, engage with clients, and shape strategies that drive business growth. With a focus on collaboration and continuous learning, you will work alongside a talented team committed to making a difference. The company provides a supportive environment with comprehensive benefits, professional development opportunities, and a culture that values inclusivity and purpose-driven work. If you're ready to take your career to the next level, this is the place for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Wellness Programs

Professional Development

Mentorship Programs

Qualifications

• 12+ years of experience in regulatory affairs or related functions.
• Broad understanding of international regulations in drug/biologics development.

Responsibilities

• Prepare client proposals and generate new business for TPIreg.
• Lead client and agency interface to strengthen relationships and grow business.

Skills

Project Management

Regulatory Affairs

Strategic Planning

Problem Solving

Communication Skills

Leadership Skills

Business Acumen

Education

B.Sc. in Life Sciences

Advanced Degree in Related Field

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat

Job description

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:

1. Responsible for preparing client proposals and generating new business for TPIreg, including leading presentations to potential RA clients, and participating in multifunctional presentations.
2. Prioritize and manage multiple simultaneous projects to meet budget (including invoice review), timelines, and client expectations; anticipate and resolve emerging issues.
3. Responsible for development and implementation of RA activities including assessments, strategies, submissions, and agency interactions, applying expert knowledge in core area of regulatory practice (e.g., CMC, Medical Devices, CTAs, US) and at least basic knowledge outside of core area.
4. Maintain target billables by obtaining new business.
5. Create opportunities to build agency relationships by participating in professional activities such as offering industry training, conference presentations, publications, and webinars.
6. Lead client and agency interface, with responsibility for strengthening relationships and growing the business. Ensure the quality of deliverables by complying with review and approval processes; identify and implement opportunities for process improvement.
7. Develop and maintain partnerships with senior decision-makers to build the business, resolve significant issues, and create opportunities.
8. Analyze data, the regulatory environment, and business objectives to make and implement recommendations, using judgment to identify innovative solutions while managing uncertainty.
9. Lead and advise clients and cross-functional teams on agency interactions. Lead decision-making and conflict resolution surrounding regulatory issues within cross-functional teams.
10. Proactively identify, share, and interpret regulatory intelligence.
11. Manage multiple projects simultaneously to ensure they are on budget, meet timelines, and client expectations.
12. Engage in continuous learning activities to provide effective consulting services and be a sought-after resource.
13. Develop and manage 0-2 regulatory direct reports at Manager level or below, including delegation, time and budget management, and skill development.
14. Travel as required.
15. 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 is preferred.
• 12+ years of relevant experience in regulatory affairs or related functions 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 is preferred.
• Leadership skills required.

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, and other relevant guidelines, with focus in areas such as CMC, biologics, pharmaceuticals, Clinical Trials, OTC/NHPs, or FDA.
• In-depth experience managing Health Authorities interactions regionally.
• Regulatory expertise in specialization areas such as medical devices, CMC, or advertising/promotion.
• Extensive experience with regulatory submission types.
• Superior project management skills for managing multiple projects within timelines in a dynamic environment.
• Advanced strategic planning and complex problem-solving skills.
• Senior leadership abilities in cross-functional, multi-disciplinary teams.
• Results-driven in team environments.
• Strong business and financial acumen.
• Excellent communication, presentation, organizational, and interpersonal skills.
• Effective at meeting deadlines and managing details.
• Proficiency with Adobe Acrobat, Microsoft Word, Excel, Outlook, and developing professional networks for business development and intelligence.

What Cencora offers

We provide compensation, benefits, and resources that foster an inclusive culture and support our team members’ purpose-driven lives. Our offerings include medical, dental, vision, and comprehensive wellness programs, support for working families, training, professional development, mentorship, and more.

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any protected class. We also provide reasonable accommodations for individuals with disabilities during the employment process. For accommodation requests, contact 888.692.2272 or [e-mail].

Accessibility Policy

Cencora is dedicated to fair and accessible employment practices and will accommodate individuals with disabilities during all employment stages upon request.

Affiliated Companies:

Innomar Strategies