Senior Principal Scientist, CMC Regulatory Affairs - Combination Products

Johnson & Johnson Innovative Medicine•Horsham, PA

1d•$137,000 - $235,750•Hybrid

About The Position

Johnson & Johnson Innovative Medicine R&D is recruiting 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 across multiple technical and regulatory areas. The role may support pre-approval and post-approval programs, synthetic or biologic products, and products in any therapeutic area. It supports the global development, registration, and lifecycle management of combination products and may serve as a core member of combination product development teams and an ad hoc member of CMC, Value Chain, and Global Regulatory Teams. The role provides expert interpretation of global combination product and medical device requirements and advises teams and management on complex, high-risk, novel, or precedent-setting issues. It applies scientific, technical, and regulatory expertise to evolving requirements, provides technical leadership and coaching, and represents Johnson & Johnson in external regulatory, industry, and scientific forums. The position is hybrid and may be located in Raritan or Titusville, New Jersey, or Spring House or Horsham, Pennsylvania. The role requires 10% domestic or international travel.

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 pharmaceutical, biotechnology, medical device, combination product, or another regulated healthcare environment.
Understanding of drug-device combination product development, including design controls, risk management, human factors/usability engineering, quality management systems, lifecycle management, and associated regulatory requirements.
Knowledge of global combination product and medical device regulatory requirements, 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 related technical or functional areas.
Ability to leverage internal and external expertise to address complex regulatory issues and develop practical business solutions.
Ability to provide guidance, coaching, and technical leadership to regulatory and cross-functional colleagues.
Ability to influence decisions across functions and organizational boundaries without direct authority and lead activities across a global, matrix organization.
Excellent written and verbal communication skills.
Strong negotiation and stakeholder management skills.
Strong strategic problem-solving skills.
Willingness to travel 10% domestically or internationally.

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 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 through scientific and regulatory expertise internally and externally.
Regulatory Affairs Certification (RAC).

Responsibilities

Serve as CMC Regulatory Affairs Combination Product lead for complex, novel, high-risk, or business-critical programs and participate in relevant development, CMC, 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 related device constituent parts.
Lead global regulatory strategies for clinical, marketing, and lifecycle management submissions, including strategic options, 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.
Lead regulatory assessments and strategic decisions concerning complex manufacturing, device, user interface, platform, and product changes with global, cross-program, or significant lifecycle impact.
Develop strategies for significant Health Authority interactions, briefing books, scientific advice meetings, workshops, and responses; represent or support CMC Regulatory Affairs in selected interactions.
Lead cross-functional initiatives related to 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 regulatory policy discussions.
Contribute to organizational positions on emerging regulatory topics, align with industry and regulatory stakeholders, and communicate external insights that influence regulatory strategies.

Benefits

Company 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, subject to policy and hire date.
Sick time: 40 hours per calendar year, with different amounts for eligible Colorado and Washington residents.
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: 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.