Manager, Regulatory Scientist (1 of 3)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Raritan New Jersey United States of America San Diego California United States of America Spring House Pennsylvania United States of America Titusville New Jersey United States of America

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 & Johnson Innovative Medicine R&D is recruiting for a Manager Regulatory Scientist. This position is a hybrid role and can be located in Titusville NJ; Raritan NJ; Spring House PA; or San Diego CA.

The Manager Regulatory Scientist is a regulatory specialist with project management capabilities responsible for supporting the end-to-end planning coordination and execution of assigned deliverables and provides support to the North America Regulatory Leader (NARL)/Global Regulatory Leader (GRL) for regulatory activities.

Principal Responsibilities:

• Lead and/or contribute to the planning preparation (including authoring of Regulatory documents e.g. Cover Letters Health Authority (HA) Forms etc.) and delivery of simple and more complex submissions throughout the products life cycle from either a global and/or regional perspective.

• Partner with the NARL/GRL to understand the competitive landscape e.g. views of HAs regulatory precedents labeling differences and therapeutic area specific issues.

• Maintain working knowledge of local regulations and submission requirements for lifecycle submissions e.g. protocols and 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 specific multi-discipline teams may be responsible for organizing and leading meetings.

• Assist in strategy development by researching regulatory and medical information in preparing submissions to regional HAs.

• Understand the regulatory framework including regional trends for various types of applications and procedures.

• Review and interpret related product approval information and current HA guidances and Advisory Committee meetings.

• Maintain up-to-date knowledge of regulations and industry environment and provide guidance on potential trends.

• Coordinate contribute and review the content of responses to queries from HAs for respective/regions and countries ensuring they are of high quality and submitted in accordance with timelines.

• May have interaction with internal and external colleagues with coordination between departments.

• May represent Johnson & Johnson externally with some degree of supervision.

Qualifications:

• A minimum of a Bachelors degree in a scientific or technical discipline is required. Advanced degree (Masters PharmD Ph.D.) in a scientific or technical discipline preferred.

• A minimum of 4 years of relevant Regulatory Affairs experience in pharmaceutical biotech or consumer over the counter (OTC) industry is required.

• Understanding of FDA and International Council for Harmonization 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.

• Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required.

• Knowledge of Health Authority (HA) organizational structure and processes for reviewing submissions is required.

• Experience in the Neuroscience therapeutic area is preferred.

• Must have excellent oral and written communication skills.

• Must have strong organization and multi-tasking skills.

• Must have the ability to proactively anticipate issues exercising judgment in developing new approaches/solutions and resolving conflicts/issues.

• Must have strong leadership capabilities with the ability to work successfully in a matrixed environment.

• The ability to effectively prioritize assignments for multiple projects simultaneously is required.

• The ability to collaborate with all levels and influence decision-making within a cross-functional organization is required.

• This position may require up to 10% travel.

The anticipated base pay range for this position in U.S. locations is $117000 to $201250.

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 corporations performance over a calendar/ performance year. Bonuses are awarded at the Companys 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 Companys 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: 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 January 6 2026. The Company may however extend this time-period in which case the posting will remain available on 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 & 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 internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning Business Writing Coaching Fact-Based Decision Making Industry Analysis Legal Support Process Improvements Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments Risk Compliance Strategic Thinking Technical Credibility

The anticipated base pay range for this position is :

$117000.00 - $201250.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).


This position is eligible to participate in the Companys long-term incentive program.


Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 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

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year


For additional general information on Company benefits please go to: - Experience:

Manager