Distinguished Scientist, CMC Regulatory Affairs - Combination Products

6084-Janssen Research & Development Legal Entity•Titusville, NJ

About The Position

Johnson & Johnson is seeking a Distinguished Scientist, CMC Regulatory Affairs – Combination Products, based in Raritan, Titusville, Horsham, or Spring House. The role provides scientific and CMC regulatory leadership for novel, ambiguous, and complex combination products and other drug-device development programs, particularly where classification or device-related regulatory expectations are evolving, inconsistently applied across regions, or lack clear precedent. The position serves as a recognized CMC Regulatory Affairs subject matter expert, develops innovative regulatory strategies, advances regulatory knowledge sharing, and contributes to external policy-shaping activities. The role partners with regulatory intelligence and policy stakeholders to identify gaps and coordinate approaches to monitoring, interpreting, disseminating, and influencing emerging policies across regions. It translates external developments into strategies, frameworks, training, and organizational recommendations, and shares learnings with the broader department and functional partners. The role leads CMC Regulatory Affairs Combination Product activities for selected complex programs and provides strategic consultation on other drug-device programs to support early risk identification, mitigation planning, and potential transition to formal combination product programs. As a senior scientific leader, the position advises and mentors colleagues and communicates priorities, progress, and organizational impact. Candidates must already be authorized to work in the country of employment; immigration sponsorship and relocation support are unavailable. The role requires 5% domestic or international travel.

Requirements

Bachelor’s degree in biological, pharmaceutical, chemical, engineering, regulatory science, medical device, or another relevant scientific discipline.
At least 12 years of relevant experience in the pharmaceutical, biotechnology, medical device, or regulated healthcare industry, inclusive of post-graduate education.
Significant experience in CMC Regulatory Affairs, Regulatory Affairs, medical device regulatory affairs, or a related regulated healthcare function.
Demonstrated expertise in drug-device combination product regulatory strategy, including development and implementation of global CMC regulatory strategies for clinical, marketing, and lifecycle submissions.
Knowledge of global combination product and medical device regulatory requirements, including medical device quality systems, device risk management, human factors/usability engineering, investigational devices, and device-related submission content.
Experience interpreting and applying evolving regulatory expectations for combined-use programs, investigational device components, cross-labeled products, and/or one-way labeled products.
Experience serving as a CMC Regulatory Affairs lead or key regulatory contributor, including developing CMC regulatory strategies, regulatory risk assessments, mitigation plans, Health Authority engagement strategies, and submission content approaches for complex combination product or combined-use programs.
Experience with device-related regulatory submissions or content, such as IDEs, 510(k)s, PMAs, technical files supporting CE marking, technical dossiers for Notified Body Opinions, EU Clinical Investigation Applications, or comparable global device regulatory submissions.
Experience preparing for, leading, or providing strategic support for Health Authority interactions involving complex CMC, device, delivery system, or combination product issues.
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.
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.
Strong scientific judgment, problem-solving, negotiation, written communication, and verbal communication skills, including the ability to present and defend CMC regulatory strategies and recommendations to senior audiences.
Willingness to travel 5% domestically or internationally.
Must already be authorized to work in the country of employment; candidates requiring future immigration sponsorship are not eligible.

Nice To Haves

Deep knowledge of global combination product, medical device, investigational device, and CMC regulatory requirements.
Recognized expertise in combined-use, cross-labeled, and other complex drug-device regulatory frameworks.
Ability to influence senior leadership and drive alignment across functions, sectors, and external partners in a global matrix environment.
Demonstrated ability to develop regulatory frameworks, governance approaches, and best practices that support consistency, scalability, and organizational learning.
Demonstrated ability to mentor and develop technical and regulatory capability within CMC Regulatory Affairs.

Responsibilities

Drive innovative CMC regulatory strategies and advance regulatory knowledge for novel, ambiguous, and complex combination products and other drug-device programs with evolving or unclear regulatory expectations.
Represent Johnson & Johnson through leadership or active participation in external regulatory, industry, trade association, benchmarking, symposium, and policy-shaping forums.
Partner 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.
Serve as the CMC Regulatory Affairs Combination Product lead for selected novel, ambiguous, or complex programs.
Provide strategic consultation on other drug-device programs to support early risk identification, regulatory strategy development, and transition to formal combination product programs when required.
Serve as a recognized subject matter expert on global combination product and drug-device regulatory frameworks, including situations where device-related requirements are undefined, ambiguous, evolving, or inconsistently applied.
Interpret regulatory expectations and provide strategic guidance to functional partners when regulatory precedent is limited.
Advise and mentor less experienced colleagues and strengthen organizational capability in combination product and device-related CMC regulatory strategy.
Translate external developments and program learning into CMC RA strategies, frameworks, training, and organizational recommendations, and share learning with the broader department and functional business partners.
Communicate priorities, progress, and organizational impact to the department.

Benefits

Consolidated retirement plan (pension) and savings plan (401(k)), subject to applicable plan terms.
Eligibility to participate in the Company’s long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with specified state variations.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental leave: 480 hours within one year of a child’s birth, adoption, or foster care placement.
Bereavement leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver leave: 80 hours in a 52-week rolling period.
Volunteer leave: 32 hours per calendar year.
Military spouse time off: 80 hours per calendar year.
Medical, dental, and vision benefits, as well as time off and other benefits provided under the applicable Collective Bargaining Agreement.