Manager, Global Labeling Product Leader

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Hybrid; EUR 82,000 - 141,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson is seeking a Manager, Global Labeling Product Leader to support labeling across Beerse, Belgium or Warsaw, Poland. The role leads primary and derived labeling, collaborates across regulatory functions, and drives labeling quality and strategy.

This position offers hybrid work options and international exposure. Required: strong regulatory labeling expertise, scientific background, and proven team leadership.

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• An advanced degree (MS, PhD, MD or PharmD) is preferred.
• Minimum 4 years of relevant experience in the pharmaceutical industry (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance).
• Minimum 3 years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent.
• Understanding of pharmaceutical drug development is required.
• Experience discussing and communicating scientific concepts is required.
• Basic understanding of worldwide regulatory guidelines for labeling is required.
• Experience leading project teams within a matrix environment; able to work with limited supervision.
• Demonstrated proactive approach and experience in continuous improvement; strong communication and collaboration.
• Experience working in document management systems.
• Ability to prioritize and manage multiple products and projects.
• Demonstrated customer-focused mindset and strategic thinking.

Responsibilities

• Lead development, revision, review, agreement, and maintenance of primary labeling (CCDS/USPI) and derived documents for assigned compounds.
• Provide advice on labeling content, processes, timelines, and scientific integrity.
• Coordinate resolution of labeling issues with potential impact on primary or derived labeling.
• Ensure high quality and compliant labeling documents.
• Contribute to global labeling strategy and understand competitors in therapeutic areas.
• Contribute to continuous improvement of the end-to-end labeling process.

Skills

Analytical reasoning

Coaching

Regulatory compliance

Regulatory development

Strategic thinking

Risk assessments

Public policies

Regulatory affairs management

Technical credibility

Process improvements

Legal support

Industry analysis

Education

Bachelor's degree in scientific discipline

Advanced degree (MS, PhD, MD or PharmD)

Tools

Document management systems

Job description

Company Overview

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Details

Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Beerse, Antwerp, Belgium, Warsaw, Masovian, Poland

Job Description: Please 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-103361 Belgium and Poland- Requisition Number: R-106224 Switzerland - Requisition Number: R-106231 United Kingdom- Requisition Number: R-106250 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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 https://www.jnj.com/innovative-medicine

We are searching for the best talent for our Manager, Global Labeling Product Leader to be based in Beerse, Belgium or Warsaw, Poland.

Purpose

Global Labeling (GL) is a function within Global Regulatory Affairs accountable for the strategic development and lifecycle management of product labeling across therapeutic areas, established products, regions, and affiliates. The scope of Global Labeling covers the end-to-end labeling process throughout the product’s lifecycle— from target labeling through the Company Core Data Sheet (CCDS): Primary labeling documents (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI)) Derived labeling documents Our Vision and Mission articulate Global Labeling’s commitment to providing high‑quality, compliant, and timely labeling that supports our stakeholders and patients worldwide.

Responsibilities

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


• Making 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.


• Contributing to and participate in 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.


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

Qualifications / Requirements

• A minimum of Bachelor’s degree in a scientific discipline is required.


• An advanced degree (MS, PhD, MD or PharmD) is preferred.


• A minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) is required.


• A minimum of 3 years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent is preferred.


• An understanding of pharmaceutical drug development is required.


• Experience in discussing and communicating scientific concepts is required.


• Basic understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required.


• Experience leading project teams within a matrix environment, combined with the ability to work largely independently with limited supervision is required.


• A demonstrated proactive approach, experience participating in continuous improvement projects, and exceptional verbal and written communication, organizational, negotiation and partnering skills is required.


• Experience working in document management systems is required.


• A successful track record of effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.


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

#LI-Hybrid

Preferred Skills

• Analytical Reasoning


• Business Writing


• Coaching


• Compliance Risk


• 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


• Strategic Thinking


• Technical Credibility

Pay Range

The anticipated pay range for this position, in the primary posting location, is: €82,000.00 - €141,450.00

The anticipated pay ranges for additional locations are: Poland – The anticipated base pay range for this position is 205,000 – 354,200

Benefits

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.


• vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health.


• service anniversary and recognition awards,


• employees - and in some location’s eligible dependents - can participate in several insurance plans.


• *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.