Senior Manager, Regulatory Affairs Business Outcomes Delivery – Digital Labeling

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 Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Warsaw, Masovian, Poland

Job Description:

Johnson & Johnson is recruiting for a Senior Manager, Digital Labeling, located in Warsaw, Poland.

In this role, you will help drive Labeling’s transformation from document-based processes to structured, digital, and data-driven labeling.

Work with Global, Regional, and National Labeling teams, to advance labeling platforms and capabilities, including artificial intelligence, Electronic Product Information, and data standards such as HL7 FHIR. You will work across Regulatory Affairs, and Technology to translate business needs into scalable digital solutions.

This is an opportunity to build the future of labeling as health authorities increasingly move toward structured and interoperable product information.

Key Responsibilities:

Improve digital labeling capabilities, including structured authoring, ePI, structured content, data standards, AI, automation, and new technologies.

Provide product leadership for labeling technology platforms, defining requirements, prioritizing capabilities, and ensuring solutions meet business and regulatory needs.

Drive the adoption of structured labeling data models and standards, including HL7 FHIR ePI and other emerging regulatory and industry standards.

Manage the digital labeling product roadmap, working across Labeling, Technology, and vendors to continuously improve solutions.

Create business value through content reuse, interoperability, AI, automation, process improvement, and measurement of outcomes.

Qualifications

Education:

University/Bachelor’s degree and generally 6-8 years of overall experience.

Advanced degree or equivalent experience in a relevant field is preferred.

Experience and Skills:

Required:

Proven experience (3-4 years) in Regulatory Affairs, Labeling, Labeling Operations, or related pharmaceutical functions.

Experience with labeling platforms, structured content, business applications, or technology-enabled transformation, including collecting business requirements.

Strong understanding of how technology, structured content, and data can improve labeling processes, user experience, content reuse, and operational efficiency.

Strong customer management, and interpersonal skills, with the ability to work across business and technology functions.

Proven ability to influence cross-functional teams and drive initiatives from requirements to solution development.

Preferred:

Experience with electronic Product Labeling/Information, pharmaceutical labeling/content management platforms.

Knowledge of regulatory data standards like FHIR, IDMP, and SPL, or related structured product information standards.

Experience with structured content and interoperability, including component-based authoring, content reuse, product data management.

Experience with technology implementation and platform management, including requirements, solution design, roadmap development, and business transformation.

Knowledge of new regulatory/labeling technologies, including artificial intelligence, automation, and structured data.

Other:

Proficiency in English required; additional language skills are an asset.

No regular business travel required

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

zł318,000.00 - zł547,400.00

Benefits:

In addition to base pay, we offer the following 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. Moreover, we offer 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. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

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