Senior Manager, Global Labeling Product Leader

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:

Horsham Pennsylvania United States of America Raritan New Jersey 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 note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-042465

• Belgium Poland - Requisition Number: R-043330

• United Kingdom - Requisition Number: R-044318

• Switzerland - Requisition Number: R-044319

• Brazil - Requisition Number: R-044320

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager Global Labeling Product Leader. This position is a hybrid role and can be located in Raritan NJ; Titusville NJ; or Horsham PA.

The Senior Manager Global Labeling Product Leader is a leading expert individual contributor who is viewed as a valuable resource by peers and manages large projects or processes. This individual will develop methods for planning directing coordinating and controlling the regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Ensure compliance with regulatory agency regulations and interpretations accounting for new and changing government regulations.

The Senior Manager Global Labeling Product Leader will be responsible for the following:

• Lead the development revision review agreement and maintenance of primary labeling (Company Core Data Sheet (CCDS) United States Package Insert (USPI) and associated patient labeling European Union Product Information (EUPI) and derived documents (labeling text for EU US)) for assigned compounds.

• Make recommendations and provide advice and guidance about labeling content processes timelines and scientific integrity. Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling or the supporting documentation. Ensure high quality and compliant labeling documents. This role may collaborate with external partners.

• Contribute to and implement the global labeling strategy including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling.

• Contribute to the continuous improvement of the end-to-end labeling process.

Qualifications:

• A minimum of a Bachelors degree in a scientific discipline is required. Advanced degree (Masters PhD PharmD) in a scientific discipline is preferred.

• A minimum of 8 years of professional work experience is required.

• A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required.

• Relevant experience in the pharmaceutical industry (e.g. Regulatory Affairs Clinical Medical Information Pharmacovigilance etc.) is required.

• An understanding of pharmaceutical drug development is required.

• Experience in discussing and communicating scientific concepts is required.

• Good understanding of worldwide regulatory guidelines and their application for guidance for labeling is required.

• Experience leading project teams in a matrix environment is required.

• Experience leading continuous improvement projects is required.

• Experience working with document management systems is required.

• Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.

• Must have exceptional verbal and written communication skills.

• Must have strong organizational negotiation and partnering skills.

• Must have the ability to work independently.

• The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred.

• The ability to drive a collaborative customer-focused learning culture is preferred.

The anticipated base pay range for this position in all other U.S. locations is $137000 to $235750.

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 November 28 2025. 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 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 () or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning Business Writing Fact-Based Decision Making Industry Analysis Legal Support Mentorship Organizing 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 :

The anticipated base pay range for this position in all other U.S. locations is $137000 to $235750.

Additional Description for Pay Transparency:

Please use the following language: Subject to the terms of their respective plans employees and/or eligible dependents are 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. 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 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 Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:

Senior Manager