Senior Principal Scientist, CMC Regulatory Affairs - Combination Products

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

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Job Description

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.  Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-105727
• Switzerland - Requisition Number: R-106762
• Belgium, Poland - Requisition Number: R-106770

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products.  This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; or Horsham, PA

The Senior Principal Scientist, CMC Regulatory Affairs - Combination Products role 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.

This 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.  Leverage 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 will apply comprehensive scientific, technical, and regulatory knowledge to address complex regulatory challenges where requirements may be evolving and precedent may be limited.  Provide 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.  Through participation in industry associations, benchmarking activities, working groups, standards-development initiatives, and regulatory policy discussions, the individual will contribute to organizational understanding of emerging regulatory expectations and influences regulatory strategies across multiple programs, therapeutic areas, and product modalities.

Principal 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.  Advanced degree (Master’s, PharmD, Ph.D.) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is preferred.

Required:

• A 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.
• The ability to leverage internal and external expertise to address complex regulatory issues and develop practical business solutions.
• The ability to provide guidance, coaching, and technical leadership to regulatory and cross-functional colleagues.
• The 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.
• 10% domestic or international travel

Preferred:

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

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