Manager, Regulatory Affairs Business Outcomes Delivery – Digital Labeling

Johnson & Johnson Innovative Medicine; Warszawa; On-site; PLN 231,000 - 399,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson is recruiting for a Manager, Digital Labeling, based in Warsaw, Poland. This role supports the transformation from document-based to structured, digital labeling and collaborates with Global, Regional, and National Labeling teams to advance platforms and capabilities including AI and data standards such as HL7 FHIR.

The role partners across Regulatory Affairs and Technology to translate business needs into effective digital solutions, helping shape the future of labeling as

Qualifications

• University/Bachelor’s degree with 2–3 years in Regulatory Affairs or related pharmaceutical functions.
• Experience with labeling platforms, structured content, or technology-enabled initiatives.
• Understanding of how data, structured content, and technology improve labeling processes.
• Strong communication skills and ability to work across business and technology teams.

Responsibilities

• Support development and implementation of digital labeling capabilities and data standards.
• Coordinate improvements, testing, and ensure solutions meet regulatory needs.
• Support structured labeling data models, HL7 FHIR, and related standards.
• Implement priorities in the digital labeling product roadmap across teams and vendors.
• Identify opportunities to improve content reuse, interoperability, automation, and user experience.

Skills

Regulatory Affairs

Labeling

Cross-functional collaboration

English communication

Education

Bachelor's degree

Advanced degree preferred

Tools

Regulatory platforms

Content management systems

HL7 FHIR knowledge

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:

Professional

All Job Posting Locations:

Warsaw, Masovian, Poland

Job Description:

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

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

You will 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 partner across Regulatory Affairs and Technology to translate business needs into effective digital solutions.

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

Key Responsibilities

• Support the development and implementation of digital labeling capabilities, including structured authoring, electronic product information, data standards, Artificial Intelligence, and new technologies.
• Support labeling technology platforms and products by capturing requirements, coordinating improvements, testing capabilities, and ensuring solutions meet business and regulatory needs.
• Support the implementation and adoption of structured labeling data models and standards, including HL7 FHIR and other emerging regulatory and industry standards.
• Implement priorities within the digital labeling product roadmap, working across Labeling, Technology, and vendors to implement and continuously improve solutions.
• Identify and deliver opportunities to improve content reuse, interoperability, automation, user experience, and labeling processes, and help measure business outcomes.

Qualifications

Education

• University/Bachelor’s degree and generally 4–6 years of overall experience.
• Advanced degree or equivalent experience in a relevant field is preferred.

Experience and Skills

Required:

• 2–3 years of experience in Regulatory Affairs, Labeling, Labeling Operations, or related pharmaceutical functions.
• Experience supporting labeling platforms, structured content, business applications, or technology-enabled initiatives, including collecting business requirements.
• Understanding of how technology, structured content, and data can improve labeling processes, user experience, content reuse, and operational efficiency.
• Strong customer focus, communication, and ability to work across business and technology teams.
• Ability to coordinate activities across teams and deliver initiatives from requirements through implementation and user adoption.

Preferred:

• Experience with electronic Product Labeling/Information, structured authoring, or pharmaceutical labeling/content management platforms.
• Knowledge of regulatory data standards such as FHIR, IDMP, SPL, or related structured product information standards.
• Experience with structured content and interoperability, including component-based authoring, content reuse, APIs, data exchange, or system integrations.
• Experience supporting technology implementation or platform/product management, including requirements, testing, and process improvement.

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:

zł231,000.00 - zł399,050.00

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.