Director, North America Regulatory Affairs Leader

Johnson & Johnson Innovative Medicine • Hopewell Township, NJ

4d • $164,000 - $282,900 • Hybrid

About The Position

The Director, North America Regulatory Leader develops, implements, and maintains North American regulatory strategies. The role executes global and North American regulatory strategies, leads the North America Regulatory Team, and provides strategic direction to cross-functional development teams. It aligns North American activities with portfolio priorities, oversees and critically reviews regulatory submissions, and leads and supports interactions with the FDA. The position also ensures regulatory compliance, supports due diligence, and advances drug development strategies that address global and regional market needs.

The role is based in Raritan or Titusville, New Jersey, or Spring House, Pennsylvania. Remote work may be considered case by case and requires Company approval. The leader directs managers and/or senior individual contributors in a matrix environment, supports their career development through coaching and feedback, and manages team operations including budget, performance, compliance, workforce planning, and succession planning.

Requirements

• 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 and lifecycle management.
• Ability to interpret regulatory requirements and precedent in the context of scientific and commercial environments.
• Working knowledge of US and EMA labeling requirements.
• In-depth knowledge of current US FDA, Health Canada (and EMA for GRL), and global regulations as they relate to 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 and written communication, organization, and multitasking skills.
• Ability to exercise independent judgment and execution in anticipating, interpreting, evaluating, and resolving complex organizational issues with novel solutions.
• Ability to encourage and embrace input from a broad range of stakeholders and capture diverse perspectives.
• Ability to identify and enhance business and work processes to foster innovation and competitiveness.

Nice To Haves

• Advanced degree (MS, PhD, or PharmD).
• Previous experience in Oncology, cell therapies, or other complex modalities.

Responsibilities

• Establish North American content requirements and timing for global dossier plans, including BLAs, NDAs, INDs, CTAs, addenda, and supplements.
• Serve as the primary point of contact for the US FDA.
• Lead regulatory response teams for FDA and Health Canada questions.
• Ensure US Business Partners are consulted and provide input on US regulatory strategies, PMR fulfillments, and other US-related issues.
• Manage routine maintenance submissions and track North American post-approval commitments; provide input on and review submission documents; and approve submissions before dispatch to regulatory authorities.
• Contribute to development of the USPI; lead North American labeling negotiation strategies and supporting documentation; and review FDA and Health Canada labeling for consistency with the CCDS and completeness and correctness of annotations.
• Direct managers and/or senior individual contributors in a matrix environment, including career development conversations, coaching, and feedback.
• Establish major aspects of Regulatory Affairs initiatives in consideration of corporate strategies and compliance regulations to support innovation and timely commercialization of new and modified products.
• Collaborate with internal stakeholders, including R&D, Marketing, and other leaders, on regulatory-compliant plans and cross-functional policies that support the product portfolio.
• Recommend product development strategy solutions based on anticipated regulatory changes and emerging issues.
• Partner with internal stakeholders to influence regulatory policies and positions and promote convergence between future regulatory policy and functional plans.
• Communicate existing policies and regulatory environment changes to management, and help develop solutions and improvements.
• Manage team operational needs, including budget, performance, compliance, workforce planning, and succession planning.
• Create a purpose-driven environment that aligns Johnson & Johnson’s Credo and Leadership Imperatives with team and enterprise strategies and goals.

Benefits

• Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Eligibility to participate in the Company’s long-term incentive program.
• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
• 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, or foster care of a child.
• Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
• Caregiver Leave: 80 hours in a 52-week rolling period.

What This Job Offers

• Job Type: Full-time
• Career Level: Director