Senior Principal Scientist, CMC Regulatory Affairs - Combination Products

About the role

The Senior Principal Scientist, CMC Regulatory Affairs - Combination Products is a senior scientific and regulatory subject matter expert responsible for leading complex combination product regulatory strategies, programs, projects, and processes spanning multiple related technical and regulatory areas. This role may support pre-approval and post-approval programs, synthetic products or biologic products, and products in any therapeutic area. The Senior Principal Scientist may serve as a core member of the combination product development team and ad hoc member of the CMC (Chemistry, Manufacturing, and Controls) team, Value Chain team for post-approval programs, and Global Regulatory Team. This role will also support the successful development, registration, and lifecycle management of combination products globally. The individual will provide expert interpretation of global combination product and medical device regulatory requirements and advise multiple project teams and management on complex, high-risk, novel, or precedent-setting regulatory issues, leveraging internal medical device regulatory expertise across Johnson & Johnson Innovative Medicine and Johnson & Johnson MedTech as needed to support development of robust and globally aligned regulatory strategies. The role applies comprehensive scientific, technical, and regulatory knowledge to address complex regulatory challenges where requirements may be evolving and precedent may be limited, provides technical leadership, mentoring, and coaching to regulatory and cross-functional colleagues, and contributes to development of organizational capability. The Senior Principal Scientist will represent Johnson & Johnson in external regulatory, industry, and scientific forums related to combination products and medical devices, participating in industry associations, benchmarking activities, working groups, standards-development initiatives, and regulatory policy discussions to contribute to organizational understanding of emerging regulatory expectations and influence regulatory strategies across multiple programs, therapeutic areas, and product modalities.

This hybrid role can be based in Raritan, NJ; Titusville, NJ; Spring House, PA; or Horsham, PA.

Note: This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements (e.g., United States: R-105727; Switzerland: R-106762; Belgium/Poland: R-106770). Applications to any requisition are considered a single submission.

Responsibilities

• Serve as CMC Regulatory Affairs (RA) Combination Product lead for complex, novel, high-risk, or business-critical combination product programs.
• Serve as a core member of one or more combination product development teams and may serve as an ad hoc member of the CMC team, Value Chain team for post-approval programs, and Global Regulatory Team.
• Provide expert interpretation of global combination product and medical device regulatory requirements and evolving Health Authority expectations for drug-device combination products and related device constituent parts used in the preparation or administration of drugs.
• Lead development of global regulatory strategies for clinical, marketing, and lifecycle management submissions involving combination products, including development of strategic options, regulatory risk assessments, mitigation plans, contingency planning, and recommendations with direct impact on program and business outcomes.
• Provide strategic oversight and expert review of device and combination product-specific submission content for clinical trial applications, marketing applications, Notified Body technical dossiers, and applicable design control deliverables; establish regulatory approaches for complex submission content where requirements are evolving, interpretation is required, or precedent is limited.
• Lead regulatory assessments and strategic decision-making for complex manufacturing, device, user interface, platform, and product changes with potential global, cross-program, or significant lifecycle impact.
• Lead development of regulatory strategies for significant Health Authority interactions, briefing books, scientific advice meetings, workshops, and responses related to complex combination product regulatory questions; represent or support representation of CMC RA during selected Health Authority interactions involving combination product regulatory strategy.
• 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 development of organizational positions on emerging regulatory topics, support alignment across industry and regulatory stakeholders, and communicate external insights that influence regulatory strategies across multiple programs, therapeutic areas, and product modalities.

Qualifications

Education: A minimum of a Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is required. An advanced degree (Master’s, PharmD, Ph.D.) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is preferred.

Required experience:

• Minimum of 10 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development.
• Experience in the pharmaceutical, biotechnology, medical device, combination product, or other regulated healthcare environment.
• Understanding of drug-device combination product development processes, including design control concepts, risk management principles, human factors/usability engineering principles, quality management system principles, lifecycle management activities, and associated regulatory requirements.
• Knowledge of global regulatory requirements and frameworks applicable to drug-device combination products and medical devices, including FDA combination product regulations and guidance documents (e.g., 21 CFR Part 4), Quality Management System Regulation (QMSR), EU Medical Device Regulation (EU MDR), and related global guidance documents.
• 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 spanning 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 provide guidance, coaching, and technical leadership to regulatory and cross-functional colleagues.
• Ability to influence decision-making 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.
• Up to 10% domestic or international travel.

Preferred experience:

• 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, benchmark