Function
Regulatory Affairs Group
Sub function
Regulatory Affairs
Category
Senior Manager, Regulatory Affairs (P8)
Location
Spring House / Raritan / Titusville / United States of America
Date posted
Jun 13 2025
Requisition number
R-015713
Work pattern
Fully Onsite
This job posting is anticipated to close on Jun 20 2025. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

JOB DESCRIPTION:

About Innovative Medicine
Our 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
Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, North America Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Raritan, NJ; or Titusville, NJ.
Remote work options may be considered on a case-by-case basis and if approved by the Company and will be available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
The Associate Director, Regulatory Leader in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of North America regulatory strategies for compounds supporting programs in the Immunology Therapeutic Area.

Principal Responsibilities:

• Develop and implement a robust North America regulatory strategy for both large and small molecules in the Immunology Therapeutic Area.
• Lead and facilitate cross functional activities related to regional strategy, including providing input on implications of regulatory strategy through participation in product-related teams.
• Provide regional regulatory input to the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) as needed.
• Serve as primary contact with Health Authorities (HA) and/or Operating Companies.
• Lead and/or participate in meetings with regulatory agencies as appropriate.
• Prepare company personnel for interactions with HA.
• Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
• Lead and oversee the preparation of dossier content for INDs, BLAs/NDAs according to the strategic plan for the region and health authority commitments.
• Perform critical review of submission documents to ensure compliance with regulatory requirements.
• Participate in the development of labeling negotiation strategies.
• Provide input into strategy with respect to clinical study design.
• Negotiate and manage regional post-approval commitments.
• Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues).
• Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge
• Provide input to Standard Operating Procedure (SOP) documents to ensure accuracy and compliance, as appropriate.

Qualifications:

• A minimum of a Bachelor’s degree is required, preferably in a scientific or technical discipline. Advanced degree (Master’s, PharmD or PhD) is preferred.
• A minimum of 8 years of health regulated industry experience is required.
• Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required.
• An understanding of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.
• An understanding of the regulatory submission and approval process is required.
• Experience interacting with Health Authorities (HAs) is required.
• Experience critically reviewing and compiling regulatory documents is required.
• Experience in the Immunology Therapeutic area is preferred.
• Must have excellent oral and written communication skills.
• Must have strong organization and multi-tasking skills.
• A proven track record of working successfully within a collaborative team environment and building positive relationships as an individual contributor is preferred.
• The ability to effectively prioritize assignments for multiple products and projects simultaneously is preferred.
• This position may require up to 10% domestic and international travel.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $168,000 to $271,400.
The anticipated base pay range for this position in all other U.S. locations is $137,000 to $235,750.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States.Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
This job posting is anticipated to close on June 5, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

• Develop and implement a robust North America regulatory strategy for both large and small molecules in the Immunology Therapeutic Area.
• Lead and facilitate cross functional activities related to regional strategy, including providing input on implications of regulatory strategy through participation in product-related teams.
• Provide regional regulatory input to the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) as needed.
• Serve as primary contact with Health Authorities (HA) and/or Operating Companies.
• Lead and/or participate in meetings with regulatory agencies as appropriate.
• Prepare company personnel for interactions with HA.
• Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
• Lead and oversee the preparation of dossier content for INDs, BLAs/NDAs according to the strategic plan for the region and health authority commitments.
• Perform critical review of submission documents to ensure compliance with regulatory requirements.
• Participate in the development of labeling negotiation strategies.
• Provide input into strategy with respect to clinical study design.
• Negotiate and manage regional post-approval commitments.
• Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues).
• Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge
• Provide input to Standard Operating Procedure (SOP) documents to ensure accuracy and compliance, as appropriate