Director, North America Regulatory Affairs Leader

Locations: Raritan, NJ; Spring House, PA; Titusville, NJ. Remote work options may be considered on a case-by-case basis.

About the role

The Director, North America Regulatory Leader is responsible for the development, implementation, and maintenance of North American regulatory strategies. This role develops and executes robust global and North American regulatory strategies, leads the NA Regulatory Team, and provides strategic direction across cross-functional development teams. The leader ensures NA alignment across portfolio priorities; oversees and critically reviews key regulatory submissions; and leads and supports interactions with FDA. The role also ensures regulatory compliance, supports due diligence, and advances drug development strategies that address global and regional market needs.

Responsibilities

• Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendums & supplements.
• Serve as primary point of contact for US FDA.
• Lead the regulatory response team for FDA and Health Canada questions.
• Ensure US Business Partners are consulted and provided input into US regulatory strategies, PMR fulfillments, and other US-related issues.
• Manage routine maintenance submissions, manage & track NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities.
• Contribute to the development of the USPI, lead the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct.
• Direct Managers and/or senior individual contributors in a matrix environment, and be accountable for meaningful career development conversations and regular coaching and feedback.
• Establish major aspects of functional Regulatory Affairs initiatives by taking into account corporate strategies and compliance regulations to drive innovation and ensure timely commercialization of new and modified products into key markets.
• Control regulatory compliant plans by collaborating with internal stakeholders including Research & Development (R&D), Marketing, and other leaders to create cross-functional policies for driving the optimum portfolio of innovative products.
• Recommend solutions for product development strategies based on anticipated regulatory changes and emerging issues to prevent potential regulatory challenges.
• Partner with internal stakeholders to influence regulatory policies and positions to drive convergence between future regulatory policy and functional plans.
• Communicate existing policies and changes in the regulatory environment to management and assist in developing solutions for known issues to implement improvements within the organization.
• Manage operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.
• Proactively create a purpose driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.

Qualifications

Education

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

Experience & Skills

• Minimum of 10 years of relevant experience.
• Experience leading interactions with Health Authorities.
• US regulatory experience.
• 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 labeling requirements, and EMA labeling requirements.
• In-depth knowledge of current US FDA, Health Canada (and EMA for GRL) and 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.
• Exercises independent judgment and execution in anticipating, interpreting, evaluating and resolving complex organization issues with novel solutions.
• Encourages and embraces input from broad range of stakeholders to capture diverse perspectives.
• Identifies and enhances business/work processes to embed an environment of innovation to remain competitive.

Preferred Qualifications

• Previous experience in Oncology, cell therapies, or other complex modalities.

Pay

Anticipated base pay range: $164,000.00 – $282,900.00. This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Benefits

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, see https://www.careers.jnj.com/employee-benefits.