Johnson & Johnson Innovative Medicine
Director, Global Regulatory Leader
Johnson & Johnson Innovative Medicine, Raritan, New Jersey, us, 08869
Director, Global Regulatory Leader
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 Function Regulatory Affairs Group
Job Sub Function Regulatory Affairs
Job Category Professional
Locations
Raritan, New Jersey, United States of America
Spring House, Pennsylvania, United States of America
Titusville, New Jersey, United States of America
Job Description 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.
Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Titusville, NJ; or Raritan, 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.
The Director, Global Regulatory Leader in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of global regulatory strategies for investigational rare disease and advanced cell therapy products supporting programs in the Immunology Therapeutic Area.
Principal Responsibilities
As the global regulatory lead for assigned projects, develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area. Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market access plans.
Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization, including providing input on implications of regulatory strategy through participation in product-related teams.
Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed.
Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs). Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
Lead and oversee key health authority documents (e.g., IND/CTA, meeting requests, briefing packages, responses, marketing applications) according to the strategic plan for the region and health authority commitments. Perform critical review of submission documents to ensure compliance with regulatory requirements.
Negotiate and manage regional post-approval commitments and global label expansion strategies.
Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams.
Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling, risk management, and development programs to meet global and regional requirements.
Support due diligence and business development assessments.
Identify and resolve regulatory issues that may affect projects or organizational objectives.
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 10 years of global health regulated industry is required.
Global regulatory experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts is required.
Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required.
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.
Understanding of the regulatory submission and approval process is required.
Experience critically reviewing and compiling regulatory documents is required.
Knowledge of the Immunology and Oncology therapeutic areas is strongly preferred.
Knowledge of advanced therapies, such as CAR‑T, is strongly preferred.
Demonstrated ability to interpret and apply regulatory requirements and precedents is required.
A proven track record in shaping global regulatory strategies, ensuring compliance, and leading direct interactions with Health Authorities is required.
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.
The ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel and practical solutions is required.
This position may require up to 10% domestic and international travel.
Required Skills Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Tactical Planning, Technical Credibility
Preferred Skills Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Tactical Planning, Technical Credibility
Compensation The anticipated base pay range for this position in the San Francisco Bay Area, CA is $189,000 to $325,450. The anticipated base pay range for this position in U.S. locations is $164,000 to $282,900.
Benefits
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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 are eligible to participate in the Company’s long‑term incentive program.
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 – 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.
Job Posting Expiration This job posting is anticipated to close on December 16, 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.
Equal Opportunity Employer 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Job Function Regulatory Affairs Group
Job Sub Function Regulatory Affairs
Job Category Professional
Locations
Raritan, New Jersey, United States of America
Spring House, Pennsylvania, United States of America
Titusville, New Jersey, United States of America
Job Description 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.
Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Titusville, NJ; or Raritan, 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.
The Director, Global Regulatory Leader in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of global regulatory strategies for investigational rare disease and advanced cell therapy products supporting programs in the Immunology Therapeutic Area.
Principal Responsibilities
As the global regulatory lead for assigned projects, develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area. Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market access plans.
Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization, including providing input on implications of regulatory strategy through participation in product-related teams.
Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed.
Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs). Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
Lead and oversee key health authority documents (e.g., IND/CTA, meeting requests, briefing packages, responses, marketing applications) according to the strategic plan for the region and health authority commitments. Perform critical review of submission documents to ensure compliance with regulatory requirements.
Negotiate and manage regional post-approval commitments and global label expansion strategies.
Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams.
Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling, risk management, and development programs to meet global and regional requirements.
Support due diligence and business development assessments.
Identify and resolve regulatory issues that may affect projects or organizational objectives.
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 10 years of global health regulated industry is required.
Global regulatory experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts is required.
Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required.
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.
Understanding of the regulatory submission and approval process is required.
Experience critically reviewing and compiling regulatory documents is required.
Knowledge of the Immunology and Oncology therapeutic areas is strongly preferred.
Knowledge of advanced therapies, such as CAR‑T, is strongly preferred.
Demonstrated ability to interpret and apply regulatory requirements and precedents is required.
A proven track record in shaping global regulatory strategies, ensuring compliance, and leading direct interactions with Health Authorities is required.
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.
The ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel and practical solutions is required.
This position may require up to 10% domestic and international travel.
Required Skills Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Tactical Planning, Technical Credibility
Preferred Skills Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Tactical Planning, Technical Credibility
Compensation The anticipated base pay range for this position in the San Francisco Bay Area, CA is $189,000 to $325,450. The anticipated base pay range for this position in U.S. locations is $164,000 to $282,900.
Benefits
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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 are eligible to participate in the Company’s long‑term incentive program.
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 – 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.
Job Posting Expiration This job posting is anticipated to close on December 16, 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.
Equal Opportunity Employer 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr