Director, North America Regulatory Affairs Leader

Johnson & Johnson•Titusville, NJ

3d•Hybrid

About The Position

Johnson & Johnson is seeking a Director, North America Regulatory Affairs Leader for its Innovative Medicine organization. The position is based in Raritan, New Jersey; Titusville, New Jersey; or Spring House, Pennsylvania. Remote work may be considered case by case with Company approval. The Director develops, implements, and maintains North American regulatory strategies, including global and regional strategies that support portfolio priorities and address market needs. The role leads the North America Regulatory Team, provides strategic direction to cross-functional development teams, oversees and critically reviews key regulatory submissions, and leads and supports interactions with the FDA. It also ensures regulatory compliance, supports due diligence, and advances drug development strategies. The role directs managers and/or senior individual contributors in a matrix environment and is accountable for career development conversations, coaching, and feedback. It manages team operational matters such as budget, performance, and compliance, and implements workforce and succession plans. The leader works across internal functions to support timely commercialization, respond to regulatory developments, and align team and enterprise goals with Johnson & Johnson’s Credo and Leadership Imperatives.

Requirements

Bachelor’s degree in a scientific or equivalent discipline.
At least 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 labelling requirements.
In-depth knowledge of current US FDA, Health Canada, and global regulations as they relate to regulatory strategy; EMA knowledge is specified for GRL.
Experience managing a portfolio of multiple products.
Ability to work successfully in a matrix environment as both a leader and an 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 enhance business processes to foster innovation.

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 BLA/NDAs, IND/CTAs, addendums, and supplements.
Serve as the primary point of contact for the US FDA.
Lead the regulatory response team for FDA and Health Canada questions.
Consult US Business Partners and obtain their 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 and lead North American labelling negotiation strategies and supporting documentation.
Review FDA and Health Canada labelling 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 view of corporate strategies and compliance regulations to support innovation and timely commercialization.
Collaborate with R&D, Marketing, and other internal leaders to create cross-functional policies and compliant plans 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 policy and functional plans.
Communicate existing policies and regulatory-environment changes to management and help develop solutions and organizational improvements.
Manage team operational matters, including budget, performance, and compliance, and implement workforce and succession plans.
Align team and enterprise strategies and goals with Johnson & Johnson’s Credo and Leadership Imperatives.

Benefits

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 specified higher 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: up to 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.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.