Director / Consultant, Regulatory Affairs

Innomar Strategies; Ontario; Hybrid; CAD 100,000 - 130,000; Full time

Job summary

A leading company in the health sector is seeking a Regulatory Affairs Manager to oversee drug submission processes and manage client relationships. The ideal candidate will have extensive experience in regulatory affairs, strong project management skills, and a commitment to continuous learning. This role involves leading a team, managing multiple projects, and ensuring compliance with health regulations while fostering an inclusive culture.

Benefits

Health benefits

Wellness programs

Support for working families

Professional development

Mentorship

Volunteer opportunities

Qualifications

• 12+ years of relevant regulatory affairs experience in pharma, biologics, or medical devices.
• Experience managing interactions with health authorities.

Responsibilities

• Prepare Health Canada drug submission content for pharmaceutical and biologic products.
• Manage multiple projects to meet budgets, timelines, and client expectations.
• Lead client and agency interactions, ensuring deliverables' quality and compliance.

Skills

Project Management

Leadership

Communication

Strategic Planning

Education

B.Sc. in life sciences or engineering

Regulatory Affairs Certification (RAC)

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. 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!

Primary Duties and Responsibilities :

• Prepare Health Canada drug submission content for pharmaceutical and biologic products, including Module 1 Product Monograph, labels, Risk Management Plan, CS-BE, Module 2 clinical and non-clinical overviews, pre-NDS meetings, and other related documents.
• Develop client proposals, generate new business, lead presentations to potential RA clients, and participate in multifunctional presentations.
• Manage multiple projects to meet budgets, timelines, and client expectations, while resolving emerging issues.
• Implement and oversee RA activities such as regulatory assessments, strategies, submissions, and agency interactions, utilizing expert knowledge in core areas.
• Maintain target billables by acquiring new business.
• Build agency relationships through professional activities like industry training, conference presentations, publications, and webinars.
• Lead client and agency interactions, ensuring deliverables' quality and compliance, and identifying process improvements.
• Develop partnerships with decision-makers to grow the business and resolve issues.
• Analyze data and the regulatory environment to make recommendations and identify innovative solutions.
• Guide clients and teams on agency interactions, lead decision-making, and manage conflicts related to regulatory issues.
• Share regulatory intelligence proactively.
• Manage multiple projects to ensure they stay on budget and meet deadlines.
• Engage in continuous learning to provide effective consulting services.
• Manage 0-2 regulatory direct reports, including delegation, skill development, and performance management.
• Travel as required.
• Perform other related duties as assigned.

Experience and Educational Requirements :

• B.Sc. in life sciences or engineering; advanced degrees preferred.
• 12+ years of relevant regulatory affairs experience in pharma, biologics, or medical devices.
• Regulatory Affairs Certification (RAC) is an asset.
• Consulting experience is preferred.

Minimum Skills, Knowledge, and Ability Requirements :

• Broad understanding of international regulations in drug, biologics, or medical device development.
• Experience managing interactions with health authorities.
• Expertise in regulatory submissions and specialization areas.
• Strong project management and strategic planning skills.
• Leadership abilities in cross-functional teams.
• Excellent communication, presentation, and interpersonal skills.
• Organizational skills with attention to detail.
• Proficiency with relevant computer software.

What Cencora offers

We provide comprehensive compensation, benefits, and resources that foster an inclusive culture and support our team members’ purpose-driven work. Our offerings include health benefits, wellness programs, support for working families, professional development, mentorship, and volunteer opportunities.