Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category:Professional
All Job Posting Locations:Toronto, Ontario, Canada
Job Description:About Innovative MedicineOur 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
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: R-075722
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, North America Regulatory Leader.
The Senior Manager, North America Regulatory Leader serves as a strategic regulatory leader responsible for shaping and executing North America regulatory strategy for assigned Immunology programs. The individual partners closely with global regulatory, clinical, and cross-functional leaders to influence development strategy, enable key development and lifecycle decisions, and ensure high-quality, timely interactions with Health Authorities.
The role requires strong regulatory judgment and a strategic mindset, with the ability to balance regulatory risk with opportunities to enable successful product development and lifecycle management.
Principal ResponsibilitiesRegulatory Strategy & Leadership- Develop, contribute to, and help shape North America regulatory strategies for assigned programs across the product lifecycle.
- Identify regulatory risks, opportunities, and mitigation strategies and translate them into actionable recommendations for development teams.
- Provide strategic regulatory input into clinical development plans, protocols, study reports, submission documents, and other key development deliverables.
- Apply knowledge of North American and global regulatory requirements, precedents, and evolving regulatory trends to inform development strategy and decision-making.
- Provide clear regulatory recommendations and effectively communicate the rationale, risks, and implications of potential strategic options.
Submission Planning & Execution- Lead the strategy, planning, preparation, and delivery of regulatory submissions across the product lifecycle, from early development through registration and post-approval activities.
- Develop and maintain submission strategies, content plans, timelines, and execution plans in partnership with global regulatory and cross-functional colleagues.
- Author and/or critically review regulatory submission components to ensure scientific quality, consistency, and compliance with applicable requirements.
- Lead regulatory applications and associated procedures through Health Authority review and approval.
Health Authority Engagement- Serve as a primary regulatory point of contact with North American Health Authorities, including the FDA and, as applicable, Health Canada.
- Develop strategies for Health Authority interactions and lead preparation for meetings, including briefing materials, anticipated questions, meeting strategy, and cross-functional preparation.
- Lead or coordinate Health Authority meetings and subsequent follow-up activities.
- Manage responses to regulatory questions and requests, ensuring that responses are scientifically sound, strategically aligned, and delivered within required timelines.
Cross-functional Collaboration- Partner closely with global regulatory, clinical, safety, CMC, statistics, medical, and other cross-functional colleagues to integrate regulatory considerations into development strategy.
- Represent the North America regulatory perspective on global and cross-functional teams.
- Lead or contribute to cross-functional submission and Health Authority interaction teams to ensure aligned, timely, and effective execution.
- Provide proactive, clear communication of regulatory strategy, risks, decisions, and status to key stakeholders.
Operational Excellence & Influence- Apply critical thinking and sound regulatory judgment to complex development and regulatory challenges.
- Develop contingency strategies and alternative regulatory pathways aligned with program and business objectives.
- Influence decision-making across a highly matrixed organization through clear recommendations, effective communication, and strong scientific and regulatory rationale.
- Identify opportunities to improve regulatory processes, ways of working, and execution.
Representation & Networking- Represent Johnson & Johnson externally with Health Authorities and, as appropriate, industry organizations and external partners.
- Build and leverage internal and external networks to strengthen regulatory strategy and execution.
Additional Scope- May serve as Regional Regulatory Leader or assume broader regulatory leadership responsibilities for assigned programs based on program needs.
QualificationsEducation & Experience- Bachelor's degree in a scientific, technical, or related discipline required; advanced degree such as a Master's, PharmD, or PhD preferred.
- Minimum regulatory experience:
- 8 years with a Bachelor's degree
- 6 years with a Master's degree or PharmD
- 4 years with a PhD
- Experience in the pharmaceutical, biotechnology, or OTC industry required.
Technical Expertise- Strong knowledge of clinical drug development and regulatory requirements and pathways across multiple phases of development.
- Experience developing regulatory strategies and translating them into executable plans.
- Experience with regulatory submissions and lifecycle activities, including INDs, NDAs/BLAs, CTAs, MAAs, and associated regulatory procedures, as applicable.
- Demonstrated experience preparing, critically reviewing, and delivering high-quality regulatory documentation.
- Experience supporting or leading interactions with FDA and other Health Authorities.
- Ability to interpret Health Authority feedback and regulatory precedent and translate them into practical development recommendations.
Leadership & Core Skills- Demonstrated strategic thinking, leadership, and ability to operate effectively within a complex matrixed environment.
- Excellent communication, collaboration, influencing, and stakeholder management skills.
- Strong critical-thinking and problem-solving skills, with the ability to evaluate complex information and provide clear recommendations.
- Ability to effectively prioritize and deliver across multiple programs, projects, and competing timelines.
- Demonstrated ability to exercise independent judgment in resolving complex regulatory, scientific, and organizational challenges.
- Experience in Immunology is preferred.
- Experience in people management, coaching, or mentoring is preferred.
Additional Information- Up to 10% travel may be required.
#LI-Hybrid
Required Skills:Preferred Skills:AI Judgement Integration, Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility
The anticipated base pay range for this position is :168,500.00 CAD - 218,500.00 CAD
Additional Description for Pay Transparency:
Under current guidelines, this position is eligible for a discretionary performance bonus.
The compensation and benefits information set forth in this posting applies to candidates hired in Canada. Candidates hired outside Canada will be eligible for compensation and benefits in accordance with their local market.
The Company uses AI in its assessment of applicants.
This job posting is for an existing position.
