Principal Scientist, CMC Regulatory Affairs - Combination Products

Johnson & Johnson • Titusville, NJ

13d • Hybrid

About The Position

This position provides CMC (Chemistry, Manufacturing, and Controls) regulatory subject matter expertise for drug-device combination products and related device constituent parts involved in the preparation or administration of drugs. This role may support pre-approval and post-approval programs, synthetic or biologic products, and products in any therapeutic area. The Principal Scientist will develop and execute regulatory strategies for assigned combination product programs, submissions, Health Authority interactions, and lifecycle management activities. This individual may serve as a core member of the combination product development team and may serve as an ad hoc member of the CMC team (or Value Chain team for post-approval programs), and Global Regulatory Team. This role will also support successful development, registration, and lifecycle management of combination products globally. This individual will provide subject matter expertise regarding global combination product and global medical device regulatory requirements and is expected to consult with other medical device regulatory experts within Johnson & Johnson Innovative Medicine or Johnson & Johnson MedTech, as needed. The role will apply in-depth regulatory and scientific knowledge to address complex issues involving one or more related disciplines, establish operational plans for assigned responsibilities, provide guidance to technical and cross-functional colleagues, and contribute to business results through effective regulatory execution.

Requirements

• A minimum of a Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is required.
• A minimum of 8 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development, inclusive of post-graduate education, is required.
• Experience in the pharmaceutical, biotechnology, medical device, combination product or other regulated healthcare environment is required.
• Knowledge of scientific, technical, regulatory, or product development principles relevant to regulated healthcare products.
• Ability to develop and execute regulatory strategies for assigned programs, submissions, Health Authority interactions, or lifecycle activities.
• Ability to collaborate cross-functionally and influence decision-making across a global, matrix organization.
• Excellent written and verbal communication skills.
• Strong analytical problem-solving skills.
• Strong attention to detail and organizational skills

Nice To Haves

• Advanced degree (Master’s, PharmD, Ph.D) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is preferred.
• 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.
• 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 is preferred.
• 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.
• Understanding of how device and combination product requirements are integrated into pharmaceutical or biologic product development, regulatory submissions, and lifecycle management activities.
• Ability to interpret and apply regulatory requirements to support scientifically sound, risk-based regulatory strategies.
• Regulatory Affairs Certification (RAC).

Responsibilities

• Provide regulatory expertise and interpretation of global combination product and global medical device regulatory requirements, including evolving global Health Authority CMC expectations for drug-device combination products, their user interface, and devices, integral or separate, involved in the preparation or administration of drugs.
• Develop and execute regulatory strategies for clinical, marketing, and lifecycle management submissions involving combination products, including regulatory risk assessments and mitigation plans.
• Review device and combination product-specific submission content for clinical trial applications, marketing applications, Notified Body technical dossiers, and development and review of applicable design control deliverables.
• Provide regulatory assessments for manufacturing, device, and product changes and determine regulatory impact globally.
• Develop regulatory strategies for Health Authority interactions, briefing books, and responses related to combination product regulatory questions.
• Participate in cross-functional initiatives related to regulatory process improvements, guidance implementation, and capability development.
• Monitor emerging global device and combination product regulations and communicate regulatory impacts to project teams and management.
• Perform other duties in support of Global Regulatory Affairs, CMC Regulatory Affairs, combination product development, registration, lifecycle management, regulatory compliance, and organizational capability-building objectives. These activities may include participation in selected due diligence, internal consultation, process improvement, training, and cross-functional regulatory initiatives.

Benefits

• Consolidated retirement plan (pension)
• Savings plan (401(k))
• Long-term incentive program
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year (or more depending on state)
• 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/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 in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Principal