Senior Principal Scientist, CMC Regulatory Affairs

pAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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. /ph3Job Function /h3pDiscovery Pre-Clinical/Clinical Development /ph3Job Sub Function /h3pRegulatory Science /ph3Job Category /h3pScientific/Technology /ph3All Job Posting Locations /h3pBeerse, Antwerp, Belgium, Warsaw, Masovian, Poland /ppWe are recruiting for a Senior Principal Scientist, CMC Regulatory Affairs
- Combination Products. This position is a hybrid role and can be located in Beerse, Belgium or Warsaw, Poland. /ppThe 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. /ph3Principal Responsibilities /h3pServe 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