Johnson & Johnson Innovative Medicine
Manager, Regulatory Scientist (1 of 3)
Johnson & Johnson Innovative Medicine, Raritan, New Jersey, us, 08869
Manager, Regulatory Scientist
Johnson & Johnson Innovative Medicine is seeking a Manager, Regulatory Scientist to support the end‑to‑end planning, coordination, and execution of regulatory submissions across the product life cycle. This hybrid role can be based in Titusville, NJ; Raritan, NJ; Spring House, PA; or San Diego, CA.
Job Description As part of the Regulatory Affairs Group, you will work with the North America Regulatory Leader (NARL) and Global Regulatory Leader (GRL) to deliver regulatory documents (e.g., cover letters, health authority forms) and lead teams on submissions from global and regional perspectives. You will maintain working knowledge of local regulations, coordinate responses to health authority queries, and provide strategic input on regulatory strategy and competitive analysis.
Principal Responsibilities
Lead and/or contribute to the planning, preparation, and delivery of simple and complex submissions throughout the product’s life cycle.
Partner with the NARL/GRL to understand competitive landscape, regulatory precedents, and labeling differences.
Maintain (regional) regulatory submission knowledge for protocols, amendments, annual reports, IND Safety Reports, PADERs, and PSURs.
Manage submission delivery for all application types per market and region.
Serve as the regulatory representative on multidisciplinary teams, organizing and leading meetings as needed.
Assist in strategy development by researching regulatory and medical information for regional health authorities.
Understand regulatory frameworks, including regional trends, for various application types.
Review and interpret product approval information and current health authority guidances.
Maintain up‑to‑date knowledge of regulations and industry trends to provide guidance on potential future changes.
Coordinate and review content of responses to queries from health authorities, ensuring high quality and timely submissions.
Collaborate with internal and external colleagues across departments.
Represent Johnson & Johnson externally when supervised.
Qualifications
Bachelor’s degree in a scientific or technical discipline (advanced degree preferred).
Minimum of 4 years of regulatory affairs experience in pharma, biotech, or OTC industry.
Strong understanding of FDA and ICH regulatory requirements (clinical, product development, labeling).
Knowledge of the drug product lifecycle from discovery to marketing.
Knowledge of health authority structures and submission processes.
Experience in the neuroscience therapeutic area is preferred.
Excellent oral and written communication skills.
Strong organization and multitasking skills.
Proactive problem‑solving with judgment for new solutions and conflict resolution.
Strong leadership capabilities in a matrixed environment.
Ability to prioritize multiple projects simultaneously.
Ability to influence decision‑making across a cross‑functional organization.
Up to 10% travel may be required.
Compensation The anticipated base pay range for this position in U.S. locations is $117,000 to $201,250.
Benefits
Vacation up to 120 hours per calendar year.
Sick time up to 40 hours per year (up to 56 hours if in Washington state).
Holiday pay (including floating holidays) up to 13 days per year.
Work, personal, and family time up to 40 hours per year.
Parental leave: 480 hours within one year of birth/adoption/foster care.
Bereavement leave: 240 hours for immediate family; 40 hours for extended family.
Caregiver leave: 80 hours in a 52‑week rolling period.
Volunteer leave: 32 hours per year.
Military spouse time‑off: 80 hours per year.
Eligibility for health, dental, vision, life insurance, short‑ and long‑term disability, and business accident insurance.
Eligibility for company‑sponsored retirement plan (401(k)) and long‑term incentive program.
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 an inclusive interview process and will accommodate applicants with disabilities. For accommodations, please contact us at https://www.jnj.com/contact-us/careers or ask internal employees to reach AskGS for your accommodation resource.
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Job Description As part of the Regulatory Affairs Group, you will work with the North America Regulatory Leader (NARL) and Global Regulatory Leader (GRL) to deliver regulatory documents (e.g., cover letters, health authority forms) and lead teams on submissions from global and regional perspectives. You will maintain working knowledge of local regulations, coordinate responses to health authority queries, and provide strategic input on regulatory strategy and competitive analysis.
Principal Responsibilities
Lead and/or contribute to the planning, preparation, and delivery of simple and complex submissions throughout the product’s life cycle.
Partner with the NARL/GRL to understand competitive landscape, regulatory precedents, and labeling differences.
Maintain (regional) regulatory submission knowledge for protocols, amendments, annual reports, IND Safety Reports, PADERs, and PSURs.
Manage submission delivery for all application types per market and region.
Serve as the regulatory representative on multidisciplinary teams, organizing and leading meetings as needed.
Assist in strategy development by researching regulatory and medical information for regional health authorities.
Understand regulatory frameworks, including regional trends, for various application types.
Review and interpret product approval information and current health authority guidances.
Maintain up‑to‑date knowledge of regulations and industry trends to provide guidance on potential future changes.
Coordinate and review content of responses to queries from health authorities, ensuring high quality and timely submissions.
Collaborate with internal and external colleagues across departments.
Represent Johnson & Johnson externally when supervised.
Qualifications
Bachelor’s degree in a scientific or technical discipline (advanced degree preferred).
Minimum of 4 years of regulatory affairs experience in pharma, biotech, or OTC industry.
Strong understanding of FDA and ICH regulatory requirements (clinical, product development, labeling).
Knowledge of the drug product lifecycle from discovery to marketing.
Knowledge of health authority structures and submission processes.
Experience in the neuroscience therapeutic area is preferred.
Excellent oral and written communication skills.
Strong organization and multitasking skills.
Proactive problem‑solving with judgment for new solutions and conflict resolution.
Strong leadership capabilities in a matrixed environment.
Ability to prioritize multiple projects simultaneously.
Ability to influence decision‑making across a cross‑functional organization.
Up to 10% travel may be required.
Compensation The anticipated base pay range for this position in U.S. locations is $117,000 to $201,250.
Benefits
Vacation up to 120 hours per calendar year.
Sick time up to 40 hours per year (up to 56 hours if in Washington state).
Holiday pay (including floating holidays) up to 13 days per year.
Work, personal, and family time up to 40 hours per year.
Parental leave: 480 hours within one year of birth/adoption/foster care.
Bereavement leave: 240 hours for immediate family; 40 hours for extended family.
Caregiver leave: 80 hours in a 52‑week rolling period.
Volunteer leave: 32 hours per year.
Military spouse time‑off: 80 hours per year.
Eligibility for health, dental, vision, life insurance, short‑ and long‑term disability, and business accident insurance.
Eligibility for company‑sponsored retirement plan (401(k)) and long‑term incentive program.
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 an inclusive interview process and will accommodate applicants with disabilities. For accommodations, please contact us at https://www.jnj.com/contact-us/careers or ask internal employees to reach AskGS for your accommodation resource.
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