Senior Principal Scientist, CMC Regulatory Affairs - Combination Products

pAt 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. As guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /ppJob Function: Discovery Pre-Clinical/Clinical Development Job Sub Function: Regulatory Science Job Category: Scientific/Technology All Job Posting Locations: Allschwil, Switzerland /ph3Senior Principal Scientist, CMC Regulatory Affairs - Combination Products /h3pThis position is a hybrid role and will be located in Allschwil, Switzerland. /ph3Principal Responsibilities /h3ulliServe as CMC Regulatory Affairs (RA) Combination Product lead for complex, novel, high-risk, or business-critical combination product programs. /liliServe 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. /liliProvide 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. /liliLead 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. /liliProvide 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. /liliEstablish regulatory approaches for complex submission content where requirements are evolving, interpretation is required, or precedent is limited. /liliLead 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. /liliLead development of regulatory strategies for significant Health Authority interactions, briefing books, scientific advice meetings, workshops, and responses related to complex combination product regulatory questions. /liliRepresent or support representation of CMC RA during selected Health Authority interactions involving combination product regulatory strategy. /liliLead cross-functional initiatives related to regulatory process improvements, guidance implementation, standards development, training, and organizational capability building. /liliProvide technical leadership, mentoring, and coaching to regulatory and cross-functional colleagues. /liliRepresent 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. /liliContribute 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. /li /ulh3Qualifications /h3ulliEducation: A minimum of a Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is required. /liliAdvanced degree (Master’s, PharmD, Ph.D.) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is preferred. /liliA minimum of 10 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development. /liliExperience in the pharmaceutical, biotechnology, medical device, combination product or other regulated healthcare environment. /liliUnderstanding 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. /liliKnowledge 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. /liliExperience supporting development, registration, or lifecycle management of pharmaceutical, biologic, medical device, and/or drug-device combination products. /liliExperience supporting global regulatory submissions, Health Authority interactions, Notified Body interactions, and device-related CMC submission content. /liliDemonstrated ability to lead complex regulatory strategies, programs, projects, or processes spanning multiple related technical or functional areas. /liliThe ability to leverage internal and external expertise to address complex regulatory issues and develop practical business solutions. /liliThe ability to provide guidance, coaching, and technical leadership to regulatory and cross-functional colleagues. /liliThe ability to influence decision-making across functions and organizational boundaries without direct authority and lead activities across a global, matrix organization. /liliExcellent written and verbal communication skills. /liliStrong negotiation and stakeholder management skills. /liliStrong strategic problem-solving skills. /lili10% domestic or international travel. /liliPreferred: Experience leading global regulatory strategies for complex pharmaceutical, biologic, medical device, and/or drug-device combination product programs. /liliExperience participating in or leading activities involving industry associations, trade organizations, standards-development initiatives, benchmarking consortia, or regulatory policy discussions. /liliDemonstrated ability to mentor, coach, and develop regulatory and technical professionals. /liliAbility to develop regulatory approaches for complex, novel, or evolving regulatory issues. /liliAbility to evaluate emerging regulatory trends and translate insights into regulatory and business strategies. /liliAbility to influence through scientific and regulatory expertise both internally and externally. /liliRegulatory Affairs Certification (RAC). /li /ulh3Required Skills /h3ulliConsulting, 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 /li /ulh3Preferred Skills /h3ulliConsulting, 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 /li /ulp#LI-Hybrid /p #J-18808-Ljbffr