The posting
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.
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):
Belgium R-108810, Poland R-108812, Switzerland R-108811, United States of America R-106742
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Regulatory Science
Job Category:
Scientific/Technology
All Job Posting Locations:
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
We are searching for the best talent for our Distinguished Scientist, CMC Regulatory Affairs -Combination Products position, to be based in Warsaw, PL.
Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position. Candidates authorized to work pursuant to a short-term status (e.g., F-1) who require future immigration sponsorship are not eligible.
Purpose: The Distinguished Scientist, CMC Regulatory Affairs – Combination Products provides scientific and CMC regulatory leadership for novel, ambiguous, and complex combination products and other drug-device development programs where combination product classification, device-related regulatory expectations are evolving, inconsistently applied across regions, or lack clear precedent. The role serves as a recognized CMC RA subject matter expert, drives innovative CMC regulatory strategies, advances regulatory knowledge sharing, and provides leadership in external policy-shaping activities related to emerging combination product and device-related regulatory expectations.
The role partners with regulatory intelligence and policy stakeholders to identify gaps in combination product and device-related regulatory intelligence, policy, guidance, and external influencing activities, and to establish a coordinated, future-oriented approach for monitoring, interpreting, disseminating, and influencing emerging policy across relevant regions. External influencing priorities and annual objectives are aligned with CMC RA SLT and CMC RA Influences priorities and the company’s business needs. The role translates external developments into CMC RA strategies, frameworks, training, and organizational recommendations and actively bridges learning back to the broader department and functional business partners.
The role also provides CMC RA Combination Product leadership for selected novel, ambiguous, or complex programs where CMC RA CP accountability is required and strategic consultation for other drug-device programs where CMC RA CP expertise supports early risk identification, mitigation planning, and efficient transition if a program evolves into a combination product. As a senior scientific leader, the role serves as a key advisor and mentor to less experienced colleagues and periodically communicates priorities, progress, and organizational impact to the department.
You will be responsible for:
- Driving innovative CMC regulatory strategies and advance regulatory knowledge for novel, ambiguous, and complex combination products and other drug-device programs where regulatory expectations are evolving, inconsistently applied across regions, or lack clear precedent.
- Representing J&J through leadership or active participation in external regulatory, industry, trade association, benchmarking, external symposia, and policy-shaping forums
- Partnering with regulatory intelligence and policy stakeholders to identify gaps and establish coordinated external influencing priorities aligned with CMC RA SLT, CMC RA Influences, and company business needs.
- Serving as the CMC RA Combination Product (CP) lead for selected novel, ambiguous, or complex programs
- Providing strategic consultation for other drug-device programs where CMC RA CP expertise can support early risk identification, regulatory strategy development, and transition to formal combination product programs if required.
- Serving as a recognized CMC RA subject matter expert for global combination product and drug-device regulatory frameworks, including situations where device-related regulatory requirements are undefined, ambiguous, evolving, or inconsistently applied across regions.
- Providing expert interpretation and strategic guidance to functional partners where regulatory precedent is limited, and serve as a key advisor and mentor to less experienced colleagues
- Actively bridging external and program learning back to the broader department and functional business partners.
- Mentoring colleagues and strengthen organizational capability in combination product and device-related CMC regulatory strategy.
Qualifications / Requirements:
- A minimum of a Bachelor’s degree in biological, pharmaceutical, chemical, engineering, regulatory science, medical device, or other relevant scientific discipline is required.
- A minimum of 12 years of relevant experience in the pharmaceutical, biotechnology, medical device, or regulated healthcare industry; inclusive of post-graduate education, is required.
- Significant experience in CMC Regulatory Affairs, Regulatory Affairs, medical device regulatory affairs, or a related regulated healthcare function is required.
- Demonstrated expertise in drug-device combination product regulatory strategy, including development and implementation of global CMC regulatory strategies for clinical, marketing, and lifecycle submissions is required.
- Demonstrated knowledge of global combination product and medical device regulatory requirements, including requirements relevant to medical device quality systems, device risk management, human factors/usability engineering, investigational devices, and device-related submission content is required.
- Experience interpreting and applying evolving regulatory expectations for combined-use programs, investigational device components, cross-labeled, and/or one-way labeled products is required.
- Demonstrated experience serving as the CMC Regulatory Affairs lead or key regulatory contributor, including development of CMC regulatory strategies, regulatory risk assessments, mitigation plans, Health Authority engagement strategies, and submission content approaches for complex combination product or combined-use programs is required.
- Experience with device-related regulatory submissions or submission content, such as IDEs, 510(k)s, PMAs, technical files to support CE marking, technical dossiers for Notified Body Opinions, EU Clinical Investigation Applications, or comparable global device regulatory submissions is required.
- Experience preparing for, leading, or providing strategic support for Health Authority interactions involving complex CMC, device, delivery system, or combination product issues is required.
- Demonstrated ability to influence senior stakeholders and cross-functional teams in a global matrix environment, including stakeholders across CMC, clinical, quality, device/delivery system, supply chain, Global Regulatory Affairs, and business development/due diligence functions is required.
- Demonstrated ability to establish or improve frameworks, templates, decision tools, best practices, training materials, or governance approaches that improve consistency, capability, and decision-making across programs is required.
- Strong scientific judgment, problem-solving skills, negotiation skills, and written and verbal communication skills, with the ability to present and defend CMC regulatory strategies and recommendations to senior audiences is required.
- 5% domestic or international travel is required.
- Deep knowledge of global combination product, medical device, investigational device, and CMC regulatory requirements is preferred.
- Recognized expertise in combined-use, cross-labeled, and other complex drug-device regulatory frameworks is preferred.
- Ability to influence senior leadership and drive alignment across functions, sectors, and external partners in a global matrix environment is preferred.
- Demonstrated ability to develop regulatory frameworks, governance approaches, and best practices that support consistency, scalability, and organizational learning is preferred.
- Demonstrated ability to mentor and develop technical and regulatory capability within CMC Regulatory Affairs is preferred.
#LI-Hybrid
Required Skills:
Preferred Skills:
Consulting, Corporate Governance, Design Mindset, Drug Discovery Development, Fact-Based Decision Making, Healthcare Trends, Interpersonal Influence, Mentorship, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Scientific Research, Stakeholder Management, Strategic Thinking, Technical Writing
The anticipated base pay range for this position is:
zł393,000.00 - zł677,350.00
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.
