Director, Regulatory Affairs

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

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for our Director, Regulatory Affairs position, to be located in Toronto, Ontario under the flexible working model (at least 3 days in office).

The Director, Regulatory Affairs provides leadership and direction for the development and execution of innovative approaches in assigned therapeutic area(s), to drive business growth in compliance with Canadian Drug Laws and Regulations, and corporate policies and procedures. The Director will lead a team of regulatory professionals to achieve strategic priorities, ensuring robust registration strategies for our pipeline medicines, and optimal outcomes for new indications/line extensions throughout the product lifecycle. As a subject matter authority on Regulatory Affairs, the Director will provide guidance to local and global business partners.

Accountabilities

• Lead and mentor a team of regulatory professionals (therapeutic and Chemistry, Manufacturing & Controls (CMC)) to deliver business objectives through development of innovative regulatory strategies implemented in close collaboration with local and global teams.
• Build a Regulatory Affairs talent pipeline through the selection and development of employees.
• Understand global regulatory trends and policies that would impact the Canadian regulatory environment.
• Shape Health Canada policies to achieve a positive regulatory environment for pipeline and marketed products.
• Coordinate management of emerging issues (e.g. new safety or quality findings) and associated risk communications.
• Ensure systems/processes support company policies and regulatory requirements and sponsor initiatives to improve the work environment.
• Collaborate with the Global Regulatory Affairs (GRA) function to advocate for Canadian needs.
• Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business portfolio priorities.
• Develop effective working relationships with opinion leaders as needed.
• Budget and resource planning.

Essential Skills/Experience

• Minimum M.Sc. in Biological or related sciences. Advanced degree preferred.
• 10+ years pharmaceutical Regulatory Affairs or related experience, including major Health Authority Interactions.
• Previous people management experience with success in developing and empowering teams

Core/Technical Proficiency Requirements

• Strong medical and scientific understanding of clinical trials, biostatistics, and drug development
• Solid knowledge of Canadian drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions
• Ability to interpret and understand laws, regulations, guidances and polices in the context of the scientific and commercial environments.
• Excellent collaborator and teammate
• Strong interpersonal and communication skills with persuasive ability to influence and negotiate with key customers (e.g., Health Canada, local and global business partners)
• Strong business insight, with excellent customer and market place focus
• Strong scientific writing skills
• Excellent problem solving and critical thinking skills
• Proven leadership skills including coaching/mentoring and motivating a team, to enable teamwork, innovation and problem-solving
• Self-motivated - sense of urgency, initiative and ability to balance multiple priorities
• Outstanding Strategic and decision-making skills

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