Associate Director, North America Regulatory Leader

Johnson & Johnson • Spring House, PA

9d • Hybrid

About The Position

The Associate Director, North America Regulatory Leader will be accountable for defining and executing U.S. regulatory strategies for Immunology programs across the product lifecycle. This role will provide regulatory leadership for assigned assets, ensure alignment with global regulatory strategy, and serve as the primary North American regulatory interface with the FDA and other applicable Health Authorities. This individual will partner closely with global and cross functional teams to enable timely development, approval, and lifecycle management of products.

Requirements

• A minimum of a Bachelor’s degree in a scientific or technical discipline is required.
• A minimum of 8 years of relevant regulatory experience with a Bachelor’s degree; a minimum of 6 years of relevant regulatory experience with a Master’s or PharmD degree; or a minimum of 4 years of relevant regulatory experience with a Ph.D. is required.
• Solid understanding of the drug development lifecycle, from discovery and clinical development through commercialization, is required.
• Working knowledge of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory requirements, including clinical research, product development, and labeling, is required.
• Must have excellent oral and written communication skills.
• Must have strong organization and multi-tasking skills.
• The ability to effectively prioritize assignments for multiple products and projects simultaneously is required.
• The ability to operate effectively as both a strategic contributor and decision maker within a global, cross‑functional organization is required.

Nice To Haves

• Advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline preferred.
• Demonstrated understanding of Health Authority organizational structures and review processes is preferred.
• Knowledge of the Immunology therapeutic area is preferred.

Responsibilities

• Develop, refine, and implement comprehensive North American regulatory strategies aligned with global product objectives.
• Anticipate regulatory risks and opportunities and develop contingency plans to support program continuity and success.
• Provide strategic regulatory input into product development plans, study design, risk-benefit assessments, and lifecycle management activities.
• Lead and facilitate North American regulatory contributions across cross‑functional teams, including Clinical, Labeling, CMC, Safety, and Submission Teams, and serves as a core member of the Global Regulatory Team (GRT).
• Work with the GRT to define global submission strategies and timelines, ensuring regional considerations are integrated early and effectively.
• Build strong working relationships with internal stakeholders and North American commercial operating companies to support product strategy and execution.
• Serve as the primary regulatory contact with North American Health Authorities and/or Operating Companies.
• Define the timing, strategy, and content for all North American Health Authority interactions within the context of the global regulatory strategy.
• Prepare company teams for Health Authority meetings and lead or participate in regulatory interactions, as appropriate.
• Negotiate and manage post‑approval commitments and ongoing regulatory obligations.
• Provide regulatory leadership for IND submissions and amendments, defining submission scope, content, and timing.
• Review and approve regulatory submissions prior to dispatch to Health Authorities.
• Lead development of clear, data‑driven responses to FDA and other Health Authority inquiries, ensuring timeliness, strategic alignment, and consistency with regulatory commitments.
• Manage lifecycle submissions, including safety reports and post‑approval changes.
• Contribute to the development and maintenance of Company Core Data Sheet (CCDS) and U.S. Prescribing Information (USPI).
• Support labeling strategy development, prepare supporting documentation, and lead or support labeling negotiations with Health Authorities.
• Review Adverse Experience (AE) safety reporting and ensure alignment with regulatory requirements.
• Review labeling content to ensure claims are supported by appropriate documentation and data.
• Demonstrate strong interpersonal and leadership skills, fostering collaboration across matrixed teams.
• Support effective resource planning and deliver high‑quality results in a fast‑paced, multi‑product environment.

Benefits

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• long-term incentive program
• Vacation - 120 hours per calendar year
• Sick time - 40 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
• Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave - 10 days
• Volunteer Leave - 4 days
• Military Spouse Time-Off - 80 hours

What This Job Offers

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