Senior Principal Scientist, CMC Regulatory Affairs - Combination Products

This hybrid role can be based in Raritan, NJ; Titusville, NJ; Spring House, PA; or Horsham, PA. The position is also posted in Switzerland (R-106762) and Belgium/Poland (R-106770); applications across requisitions are considered a single submission.

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 technical and regulatory areas. The role supports pre‑approval and post‑approval programs for synthetic or biologic products across therapeutic areas, serving as a core member of combination product development teams and ad hoc member of CMC, Value Chain, and Global Regulatory teams. The incumbent provides expert interpretation of global combination product and medical device regulatory requirements, advises on high‑risk or precedent‑setting issues, leverages internal device regulatory expertise across Innovative Medicine and MedTech, and represents Johnson & Johnson in external regulatory, industry, and scientific forums.

Responsibilities

• Serve as CMC Regulatory Affairs 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; ad hoc member of CMC team, Value Chain team (post‑approval), 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 device constituent parts.
• Lead development of global regulatory strategies for clinical, marketing, and lifecycle management submissions, including strategic options, regulatory risk assessments, mitigation plans, contingency planning, and recommendations with direct program and business impact.
• 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 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 CMC RA representation in selected Health Authority 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 and communicate external insights that influence strategies across programs, therapeutic areas, and product modalities.

Qualifications

Education

• Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline (required).
• Advanced degree (Master’s, PharmD, Ph.D.) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline (preferred).

Required experience

• Minimum 10 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development.
• Experience in pharmaceutical, biotechnology, medical device, combination product, or other regulated healthcare environment.
• Understanding of drug‑device combination product development processes: design control concepts, risk management principles, human factors/usability engineering, quality management system principles, lifecycle management activities, and associated regulatory requirements.
• Knowledge of global regulatory requirements and frameworks for drug‑device combination products and medical devices, including FDA combination product regulations and guidance (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 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

• Leading global regulatory strategies for complex pharmaceutical, biologic, medical device, and/or drug‑device combination product programs.
• Participating in or leading activities involving industry associations, trade organizations, standards‑development initiatives, benchmarking consortia, or regulatory policy discussions.
• Mentoring, coaching, and developing regulatory and technical professionals.
• Developing regulatory approaches for complex, novel, or evolving regulatory issues.
• Evaluating emerging regulatory trends and translating insights into regulatory and business strategies.
• Influencing through scientific and regulatory expertise both internally and externally.
• Regulatory Affairs Certification (RAC).

Skills

Required skills

• Consulting, Corporate Governance, Drug Discovery Development, Fact‑Based Decision Making, Healthcare Trends, Interpersonal Influence, Mentorship, Public Policies, Regulatory Compliance, Regulatory Development, Regulatory Environment, Scientific Research, Strategic Thinking, Subject Matter Experts (SME) Collaboration, Tactical Planning, Technical Credibility, Technical Writing

Preferred skills

• Same as required skills; depth and demonstrated application in combination product regulatory affairs is preferred.

Pay

Anticipated base pay range: $137,000.00 – $235,750.00 per year. Eligible for the Company’s consolidated retirement plan (pension), savings plan (401(k)), and long‑term incentive program, subject to the terms of their respective plans.

Benefits

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year (Colorado residents: 48 hours; Washington residents: 56 hours)
• 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 birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours