Manager, Global Labeling Product Leader

Job Function: Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations

High Wycombe, Buckinghamshire, United Kingdom

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 High Wycombe, United Kingdom.

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.

You will be responsible for:

• 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.

Required Skills

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