Director/Consultant, Regulatory Affairs

Cencora; Ontario; On-site; CAD 80,000 - 120,000; Full time

Job summary

Join a forward-thinking company dedicated to creating healthier futures. This role focuses on regulatory affairs, where you will lead client interactions, manage multiple projects, and drive strategic initiatives. With a commitment to professional growth and a supportive culture, you will have the opportunity to make a significant impact in the health sector. The company offers a comprehensive benefits package, including wellness support and professional development resources, ensuring you can thrive both personally and professionally. If you are passionate about making a difference, this is the perfect opportunity for you.

Benefits

Medical Benefits

Dental Benefits

Vision Care

Paid Parental Leave

Adoption Assistance

Professional Development Resources

Mentorship Opportunities

Employee Resource Groups

Volunteer Activities

Qualifications

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

Responsibilities

• Prepare client proposals and generate new business for TPIreg.
• Lead client and agency interface, strengthening relationships and growing the business.

Skills

Regulatory Affairs

Project Management

Analytical Skills

Leadership

Communication Skills

Education

B.Sc. in Life Sciences

Advanced Degree in Related Field

Tools

Adobe Acrobat

Microsoft Word

Microsoft Excel

Microsoft Outlook

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 areas of regulatory practice (e.g., CMC, Medical Devices, CTAs, US) and at least basic knowledge outside of core areas.
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 simultaneous projects to ensure they are on budget, meet timelines, and satisfy 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, skill and knowledge development.
14. Travel as required.
15. 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 is preferred.
• 12+ years of relevant experience in regulatory affairs or related functions in pharmaceutical/biologic/medical device development/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 knowledge of 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 specialized areas such as medical devices, CMC, or advertising/promotion.
• Extensive experience with a wide range of 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 for resolving complex issues effectively and efficiently.
• Demonstrated senior leadership abilities in cross-functional, multidisciplinary teams.
• Ability to drive results in a team environment, with strong business and financial acumen.
• Strong analytical, mathematical, and communication skills, both oral and written.
• Excellent presentation, leadership, interpersonal, and organizational skills.
• Attention to detail and ability to meet deadlines consistently.
• Proficiency with computers, including Adobe Acrobat, Microsoft Word, Excel, and Outlook; ability to develop professional networks for business development and regulatory intelligence.

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. Our offerings include medical, dental, vision care, and a comprehensive suite of wellness benefits, including support for working families, backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. We also offer various training programs, professional development resources, mentorship opportunities, employee resource groups, volunteer activities, and more.

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 protected class. We ensure compliance with all applicable laws and prohibit harassment. We also provide reasonable accommodations during the employment process upon request, available via phone or email at [e-mail].

Accessibility Policy

We are committed to fair and accessible employment practices and will accommodate individuals with disabilities during recruitment, assessment, hiring, and employment as required.

Affiliated Companies:

Innomar Strategies