Director, Regulatory Affairs

Johnson & Johnson MedTech is recruiting for a Director, Regulatory Affairs to be located in Markham, Ontario. This role will work a Flex/Hybrid schedule with a minimum of 3 days per week in the office. There is NO remote option available.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. That is why we foster a culture of inclusion and belonging where all perspectives, abilities, and experiences are valued and our people can reach their potential.

Key Responsibilities:

• Lead and mentor a group of regulatory professionals to deliver business objectives in close collaboration with local and global teams.
• Support the building of a Regulatory Affairs talent pipeline through the selection and development of regulatory professionals.
• Conduct analysis and risk assessment of pipeline projects, develop successful regulatory strategies to achieve desired business outcomes.
• Lead the preparation and compilation of regulatory submissions for new and amended products, investigational testing, and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products.
• Manage the preparation and review of responses to Health Canada queries in a timely manner.
• Lead interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval, optimal labeling, and implementation of local regulatory strategies.
• Collaborate with global regulatory teams to facilitate regulatory activities.
• Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities.
• Develop effective working relationships with opinion leaders as needed.
• Handle emerging issues and associated risk communications to stakeholders.
• Provide regulatory guidance to internal collaborators on messaging and promotional material review.
• Monitor the regulatory environment, interpret changes, analyze gaps, and conduct impact assessments.
• Influence and shape Health Canada policies to create a supportive regulatory environment for pipeline products.
• Actively contribute to improving critical departmental processes and initiatives to enhance the internal work environment.

Qualifications

Minimum Qualifications:

• Minimum Bachelor’s Degree required, Advanced Degree strongly preferred. Biological or related sciences field of study desired.
• At least 10+ years of relevant Regulatory Affairs or related experience required.
• Previous people leadership experience strongly preferred.
• Solid understanding of Canadian laws, regulations, guidelines, and policies, and the Health Canada organizational structure and processes for the review and approval of health product submissions required.
• Strong working knowledge of Canadian regulatory submission requirements required.
• Understanding of the application of laws, regulations, guidances, and policies to specific projects.
• Ability to interpret and understand Regulations in the context of the scientific and commercial environment.
• Ability to interpret, summarize, and communicate clinical data.
• Well-defined problem-solving and analytical skills with demonstrated ability to think strategically.
• Strong negotiation and influencing skills.
• Well-developed project management skills and ability to manage multiple priorities.
• Strong communication skills, both verbal and written; proficiency in French is an asset.
• Well-developed interpersonal, team, and leadership skills to facilitate teamwork and problem-solving.
• People supervisory and coaching skills.
• Excellent customer and marketplace focus.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing, and retaining a workforce that reflects the diversity of our customers and communities is essential to our success.