Description

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 https://www.jnj.com

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

People Leader

All Job Posting Locations

Beerse, Antwerp, Belgium, Leiden, Netherlands, Warsaw, Masovian, Poland

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

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 ID R-033136
• Switzerland - Requisition ID R-033135

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

Director, Labeling Science and Technology Leader – Cross-Regional Regulatory Affairs

Are you ready to shape the future of regulatory labeling? At Johnson & Johnson Innovative Medicine R&D, we are reimagining how science, technology, and innovation come together to improve lives. We are looking for a dynamic and visionary leader to join our Cross-Regional Regulatory Affairs team as Director, Labeling Science and Technology Leader. In this pivotal role, you will lead transformative initiatives across EMEA, APAC, and LATAM, supporting over 150 Local Operating Companies (LOCs) and driving the evolution of labeling through scientific expertise, cutting‑edge technologies and strategic leadership.

Purpose

This position within the Cross-Regional Operations & Strategic Support (C-ROSS) group in Regional Regulatory Affairs leads a team managing local and regional labeling documents (including translations) working across the EMEA, APAC and LATAM regions in support of more than 150 Local Operating Companies (LOCs). The position supports the J&J Innovative Medicines Portfolio from initial product registration through the product lifecycle, in compliance with internal J&J policy and local HA requirements and in close collaboration with R&D, LOCs, Regional and Global stakeholders. The position is the key regional contact point for projects to leverage and implement innovative technology (e.g., digital labeling, translation technology) and to improve the local and regional labeling processes and compliance. The position leads and adapts to change, manages complexity and works collaboratively and builds alliances with relevant parts of the business, including Regulatory Affairs and other R&D functions, to leverage expertise, resources, processes and tools.

Key Responsibilities

• Build and lead a high-performing cross-regional team focused on transforming how we deliver local and regional labeling from a content, process and technology perspective
• Drive strategic innovation in scientific labeling content and technology, leveraging digital labeling, translation tools, and Generative AI in collaboration with stakeholders (especially Global Labeling colleagues who are responsible for the maintenance of target and primary labeling) to enhance efficiency and ensure compliance with J&J policies and local health authority requirements.
• Champion continuous improvement initiatives across regions and functions, optimizing the labeling processes with a strong focus on compliance and operational excellence in the regional and local context.
• Develop and mentor talent, fostering a culture of growth and learning through targeted training in scientific labeling, regulatory processes, and emerging technologies.
• Drive change in response to evolving regulatory and business landscapes, implementing transformative solutions and building strong cross-functional alliances.
• Establish performance metrics, forecasting capabilities, and analytics to monitor progress, ensure compliance, and optimize resources.
• Contribute to strategic projects at local, regional, and global levels, including initiatives related to talent, culture, and technology.
• Assess and manage budget impact for labeling-related projects and contribute to financial planning decisions.

Required Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree (Master’s, PhD, PharmD) preferred.
• Deep understanding of the global pharmaceutical landscape, including R&D, regulatory affairs, and commercial strategy.
• Minimum of 12 years of relevant experience (including 8 years in pharmaceutical regulatory affairs) with at least 5 years of leadership experience in a global or multinational setting.
• Proven expertise in regulatory labeling, including content development, document management, translations, and digital labeling technologies.
• Minimum of 5 years of experience leading teams and projects in a matrixed environment, with a proven track record of people leadership, coaching and talent development.
• Strong cross-cultural awareness and interpersonal skills, with the ability to build effective relationships across all levels of the organization.
• Ability to thrive in a fast-paced, dynamic environment while managing multiple priorities.
• Experience in leading continuous improvement initiatives and proficiency in project management tools and labeling technologies.
• Exceptional communication, organizational, negotiation, and collaboration skills.