Senior Principal Scientist, CMC Regulatory Affairs - Combination Products in Allschwil

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• Function: Discovery & Pre-Clinical/Clinical Development
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• Function: Regulatory
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• Category: Scientific/Technology All
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• Posting
• Locations: Allschwil, Switzerland
• Senior Principal Scientist, CMC Regulatory Affairs - Combination Products

This position is a hybrid role and will be located in Allschwil, Switzerland.

• 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, Pharm D, Ph. D.) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is preferred.
• 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).
• 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
• 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
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