Director, North America Regulatory Leader (Oncology)

J&J Family of Companies; Old Toronto; On-site; CAD 120,000 - 200,000; Full time

Job summary

An established industry player is seeking a Director, North America Regulatory Leader to guide regulatory strategies in oncology. This pivotal role involves developing and implementing robust regulatory frameworks, leading interactions with health authorities, and ensuring compliance with stringent regulations. The ideal candidate will possess extensive experience in drug development and a strong understanding of regulatory requirements. Join a team dedicated to advancing healthcare solutions and making a meaningful impact on patient lives. Your expertise will drive innovation and shape the future of medicine in a collaborative environment.

Qualifications

• 10-12 years of relevant experience in regulatory affairs.
• Strong knowledge of FDA and Health Canada regulations.

Responsibilities

• Develop and implement North American regulatory strategies.
• Lead interactions with FDA and Health Canada.

Skills

Regulatory Strategy Development

Health Authority Interactions

Drug Development Knowledge

Project Management

Communication Skills

Education

Bachelor’s Degree in Scientific Discipline

Advanced Degree (MS, PhD, PharmD)

Job description

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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Toronto, Ontario, Canada

Job Description:

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 a Director, North America Regulatory Leader (Oncology) to be in Toronto, Canada.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-007098

Canada - Requisition Number: R-012908

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose:

The Director, North American Regulatory Leader, is responsible for the development, implementation and maintenance of North American regulatory strategies.

You will be responsible for:

1. The development, implementation and maintenance of robust North American regulatory strategies.
2. Leading the North America discussions during the Global Regulatory Team and being a key contributor on multiple cross-functional teams such as the Compound Development Team (CDT).
3. Providing strategic direction to the teams and critical review of key Health Authority submissions such as IND/NDA/BLAs, meeting requests, briefing documents, response documents, and marketing and supplemental applications.
4. Ensuring that NA regulatory strategies are in alignment with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile.
5. Interacting with the Health Authorities, the NARL will lead and/or participate in meetings with FDA, Health Canada, and other Health Authorities (HAs) if appropriate.
6. Developing a regulatory strategy that will deliver global and/or regional needs with initial focus on the key markets identified.
7. Ensuring business compliance, supporting due diligence activities, implementing drug development strategies, and adhering to regulatory standards.
8. Establishing North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendums & supplements.
9. Serving as primary point of contact for US FDA.
10. Ensuring US Business Partners are consulted and provided input into US regulatory strategies, PMR fulfillments, and other US-related issues.
11. Leading the regulatory response team for FDA and Health Canada questions.
12. Managing routine maintenance submissions, managing & tracking NA post-approval commitments, providing input and reviewing submission documents, as well as approving submissions before dispatching to regulatory authorities.
13. Contributing to the development of the USPI, leading the development of NA labeling negotiation strategies, and developing supporting documentation for labeling, as well as reviewing FDA and Health Canada labeling to ensure consistency with the CCDS and ensuring that annotations are complete and correct.
14. Engaging in TA and department workstreams and initiatives to lead scientific innovation and process improvements/efficiencies.

Qualifications / Requirements:

Education:

• Minimum of a Bachelor’s degree in scientific or equivalent discipline is required.
• Advanced Degree (MS, PhD, PharmD) is preferred.

Required:

• Minimum of 10-12 years of relevant work experience.
• Experience leading interactions with Health Authorities.
• Broad understanding and experience in drug development, including early and late development, as well as a broad understanding of lifecycle management.
• Ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment.
• Working knowledge of US labelling requirements.
• In-depth knowledge of current US FDA, Health Canada, and/or global regulations as they relate to overall regulatory strategy.
• Experience managing a portfolio of multiple products.
• Ability to work successfully in a matrixed environment as a leader and individual contributor.
• People and project management skills, strong oral & written communication skills, and organization & multi-tasking skills.

Preferred:

• Previous experience in the oncology therapeutic area and/or advanced therapy modality.