Senior Principal Scientist, CMC Regulatory Affairs - Combination Products

Johnson & Johnson•Titusville, NJ

17h•Hybrid

About The Position

Johnson & Johnson Innovative Medicine R&D is seeking a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This senior scientific and regulatory subject matter expert leads complex combination-product regulatory strategies, programs, projects, and processes spanning multiple technical and regulatory areas. The role may support pre-approval or post-approval programs, synthetic or biologic products, and products in any therapeutic area. It is a hybrid position based in Raritan, New Jersey; Titusville, New Jersey; Spring House, Pennsylvania; or Horsham, Pennsylvania. The role supports the development, registration, and global lifecycle management of combination products. The Senior Principal Scientist provides expert interpretation of global combination-product and medical-device requirements and advises project teams and management on complex, high-risk, novel, or precedent-setting regulatory issues. The role applies comprehensive scientific, technical, and regulatory expertise to challenges where requirements are evolving or precedent is limited, and leverages internal medical-device expertise across Johnson & Johnson Innovative Medicine and MedTech as appropriate. The position may serve as a core member of combination-product development teams and an ad hoc member of CMC, post-approval Value Chain, and Global Regulatory teams. It also provides technical leadership, mentoring, and coaching to regulatory and cross-functional colleagues, and represents Johnson & Johnson in external regulatory, industry, and scientific forums. Through participation in industry associations, standards-development activities, working groups, benchmarking, and regulatory policy discussions, the role contributes to organizational understanding of emerging expectations and informs regulatory strategies across programs, therapeutic areas, and product modalities.

Requirements

Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline.
At least 10 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development.
Experience in the pharmaceutical, biotechnology, medical-device, combination-product, or another regulated healthcare environment.
Understanding of drug-device combination-product development, including design control, risk management, human factors/usability engineering, quality management systems, lifecycle management, and related regulatory requirements.
Knowledge of global requirements and frameworks for drug-device combination products and medical devices, including FDA combination-product regulations and guidance such as 21 CFR Part 4, QMSR, EU MDR, and related global guidance.
Experience supporting development, registration, or lifecycle management of pharmaceutical, biologic, medical-device, and/or drug-device combination products.
Experience supporting global regulatory submissions, Health Authority interactions, Notified Body interactions, and device-related CMC submission content.
Demonstrated ability to lead complex regulatory strategies, programs, projects, or processes across multiple related technical or functional areas.
Ability to leverage internal and external expertise to address complex regulatory issues and develop practical business solutions.
Ability to guide, coach, and provide technical leadership to regulatory and cross-functional colleagues.
Ability to influence decisions across functions and organizational boundaries without direct authority and to lead activities in a global, matrix organization.
Excellent written and verbal communication skills.
Strong negotiation and stakeholder-management skills.
Strong strategic problem-solving skills.
Willingness to travel domestically or internationally 10% of the time.

Nice To Haves

Advanced degree (Master’s, PharmD, or Ph.D.) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline.
Experience leading global regulatory strategies for complex pharmaceutical, biologic, medical-device, and/or drug-device combination-product programs.
Experience participating in or leading activities involving industry associations, trade organizations, standards-development initiatives, benchmarking consortia, or regulatory policy discussions.
Demonstrated ability to mentor, coach, and develop regulatory and technical professionals.
Ability to develop regulatory approaches for complex, novel, or evolving regulatory issues.
Ability to evaluate emerging regulatory trends and translate insights into regulatory and business strategies.
Ability to influence internally and externally through scientific and regulatory expertise.
Regulatory Affairs Certification (RAC).

Responsibilities

Lead CMC Regulatory Affairs combination-product strategy for complex, novel, high-risk, or business-critical programs.
Serve as a core member of one or more combination-product development teams and, as needed, as an ad hoc member of CMC, post-approval Value Chain, and Global Regulatory teams.
Interpret global combination-product and medical-device requirements and evolving Health Authority expectations for drug-device combination products and device constituent parts used to prepare or administer drugs.
Develop global regulatory strategies for clinical, marketing, and lifecycle-management submissions, including strategic options, regulatory risk assessments, mitigation plans, contingency planning, and recommendations.
Provide strategic oversight and expert review of device- and combination-product-specific content for clinical trial applications, marketing applications, Notified Body technical dossiers, and applicable design-control deliverables.
Establish regulatory approaches for complex submission content when requirements are evolving, interpretation is required, or precedent is limited.
Lead regulatory assessments and strategic decisions for complex manufacturing, device, user-interface, platform, and product changes with potential global, cross-program, or significant lifecycle impact.
Develop strategies for significant Health Authority interactions, briefing books, scientific advice meetings, workshops, and responses to complex combination-product regulatory questions.
Represent or support CMC Regulatory Affairs in selected Health Authority interactions involving combination-product strategy.
Lead cross-functional initiatives involving regulatory process improvements, guidance implementation, standards development, training, and organizational capability building.
Provide technical leadership, mentoring, and coaching to regulatory and cross-functional colleagues.
Represent Johnson & Johnson Innovative Medicine in external combination-product and medical-device regulatory activities, including industry associations, trade organizations, standards-development activities, working groups, benchmarking initiatives, and policy discussions.
Contribute to organizational positions on emerging regulatory topics, support alignment among industry and regulatory stakeholders, and communicate external insights that inform strategies across programs and product modalities.

Benefits

Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different provisions for employees residing in Colorado or Washington.
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 the birth, adoption, or foster care of a child.
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.