Johnson & Johnson Innovative Medicine
Manager, Regulatory Scientist (1 of 3)
Johnson & Johnson Innovative Medicine, Titusville, New Jersey, us, 08560
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Manager, Regulatory Scientist (1 of 3)
role at
Johnson & Johnson Innovative Medicine . Join our team of scientists and regulatory experts dedicated to developing life‑saving therapies that bring hope to patients worldwide.
Locations
Titusville, New Jersey
Raritan, New Jersey
Spring House, Pennsylvania
San Diego, California
Overview This hybrid position is a regulatory specialist with project‑management capabilities responsible for supporting the end‑to‑end planning, coordination, and execution of assigned deliverables and providing support to the North America Regulatory Leader (NARL) and Global Regulatory Leader (GRL) for regulatory activities.
Principal Responsibilities
Lead and/or contribute to the planning, preparation (including authoring of regulatory documents such as cover letters and Health Authority forms) and delivery of simple and complex submissions throughout the product’s lifecycle from global and regional perspectives.
Partner with the NARL/GRL to understand competitive landscape, regulatory precedents, labeling differences, and therapeutic‑area specific issues.
Maintain working knowledge of local regulations and submission requirements for lifecycle submissions (protocols, protocol amendments, informational amendments, annual reports, IND Safety Reports, PADERs, and PSURs).
Manage submission delivery of all application types per market and/or region.
Serve as the regulatory representative on multi‑discipline teams, organizing and leading meetings as needed.
Assist in strategy development by researching regulatory and medical information for regional Health Authority submissions.
Understand the regulatory framework, including regional trends, for various application types and procedures.
Review and interpret product approval information and current Health Authority guidance and Advisory Committee meetings.
Provide guidance on potential regulatory trends and industry developments.
Coordinate, contribute, and review responses to Health Authority queries, ensuring high quality and timely submission.
Interact with internal and external colleagues, coordinating across departments.
Represent Johnson & Johnson externally under supervision.
Qualifications
Minimum bachelor’s degree in a scientific or technical discipline; advanced degree (Master’s, PharmD, Ph.D.) preferred.
At least 4 years of regulatory affairs experience in pharmaceutical, biotech, or OTC industry.
Knowledge of FDA and ICH regulatory requirements for clinical research, product development, and labeling.
Understanding of the drug product lifecycle from discovery to marketing.
Knowledge of Health Authority organizational structure and submission processes.
Experience in the neuroscience therapeutic area preferred.
Excellent oral and written communication skills.
Strong organizational and multi‑tasking abilities.
Proactive problem‑solving skills and judgment in developing new solutions.
Leadership capabilities and ability to work in a matrix environment.
Ability to prioritize assignments across multiple projects.
Ability to collaborate with all levels and influence decision making.
Up to 10% travel may be required.
Salary and Benefits The anticipated base pay range for this position in the U.S. is $117,000 – $201,250 per year. The role is eligible for an annual performance bonus per company guidelines. Additional benefits include medical, dental, vision, life and disability insurance, business accident insurance, group legal insurance, and participation in the company’s 401(k) retirement plan.
Time‑off Benefits
Vacation: up to 120 hours per calendar year.
Sick time: up to 40 hours per calendar year (up to 56 hours for employees in Washington).
Holiday pay and floating holidays: up to 13 days per calendar year.
Work, personal, and family time: up to 40 hours per calendar year.
Equal Opportunity Employment 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.
This job posting will remain active until January 6, 2026, unless the posting is extended.
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Manager, Regulatory Scientist (1 of 3)
role at
Johnson & Johnson Innovative Medicine . Join our team of scientists and regulatory experts dedicated to developing life‑saving therapies that bring hope to patients worldwide.
Locations
Titusville, New Jersey
Raritan, New Jersey
Spring House, Pennsylvania
San Diego, California
Overview This hybrid position is a regulatory specialist with project‑management capabilities responsible for supporting the end‑to‑end planning, coordination, and execution of assigned deliverables and providing support to the North America Regulatory Leader (NARL) and Global Regulatory Leader (GRL) for regulatory activities.
Principal Responsibilities
Lead and/or contribute to the planning, preparation (including authoring of regulatory documents such as cover letters and Health Authority forms) and delivery of simple and complex submissions throughout the product’s lifecycle from global and regional perspectives.
Partner with the NARL/GRL to understand competitive landscape, regulatory precedents, labeling differences, and therapeutic‑area specific issues.
Maintain working knowledge of local regulations and submission requirements for lifecycle submissions (protocols, protocol amendments, informational amendments, annual reports, IND Safety Reports, PADERs, and PSURs).
Manage submission delivery of all application types per market and/or region.
Serve as the regulatory representative on multi‑discipline teams, organizing and leading meetings as needed.
Assist in strategy development by researching regulatory and medical information for regional Health Authority submissions.
Understand the regulatory framework, including regional trends, for various application types and procedures.
Review and interpret product approval information and current Health Authority guidance and Advisory Committee meetings.
Provide guidance on potential regulatory trends and industry developments.
Coordinate, contribute, and review responses to Health Authority queries, ensuring high quality and timely submission.
Interact with internal and external colleagues, coordinating across departments.
Represent Johnson & Johnson externally under supervision.
Qualifications
Minimum bachelor’s degree in a scientific or technical discipline; advanced degree (Master’s, PharmD, Ph.D.) preferred.
At least 4 years of regulatory affairs experience in pharmaceutical, biotech, or OTC industry.
Knowledge of FDA and ICH regulatory requirements for clinical research, product development, and labeling.
Understanding of the drug product lifecycle from discovery to marketing.
Knowledge of Health Authority organizational structure and submission processes.
Experience in the neuroscience therapeutic area preferred.
Excellent oral and written communication skills.
Strong organizational and multi‑tasking abilities.
Proactive problem‑solving skills and judgment in developing new solutions.
Leadership capabilities and ability to work in a matrix environment.
Ability to prioritize assignments across multiple projects.
Ability to collaborate with all levels and influence decision making.
Up to 10% travel may be required.
Salary and Benefits The anticipated base pay range for this position in the U.S. is $117,000 – $201,250 per year. The role is eligible for an annual performance bonus per company guidelines. Additional benefits include medical, dental, vision, life and disability insurance, business accident insurance, group legal insurance, and participation in the company’s 401(k) retirement plan.
Time‑off Benefits
Vacation: up to 120 hours per calendar year.
Sick time: up to 40 hours per calendar year (up to 56 hours for employees in Washington).
Holiday pay and floating holidays: up to 13 days per calendar year.
Work, personal, and family time: up to 40 hours per calendar year.
Equal Opportunity Employment 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.
This job posting will remain active until January 6, 2026, unless the posting is extended.
#J-18808-Ljbffr