Director, Regulatory Affairs (Canada) - Johnson & Johnson Canada, Inc.

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 3 days per week in 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.

Learn more at https://www.jnj.com.

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.

At Johnson & Johnson, we all belong.

The Director, Regulatory Affairs will be responsible for leading regulatory activities to obtain and maintain RA registration status in compliance with Canadian laws and regulations, as well as corporate policies and procedures.

The Director, as the leader of the local RA team, will develop and implement regulatory strategies to meet project deliverables.

As a subject matter authority for Regulatory Affairs, the individual will provide guidance to local and global business partners.

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 labelling and implementation of local regulatory strategies.

• Collaborate with g...