Principal Scientist, CMC Regulatory Affairs - Combination Products

Job description

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. 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. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Regulatory Science Job Category: Scientific/Technology All Job Posting Locations: Beerse, Antwerp, Belgium, Warsaw, Masovian, Poland 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-093413 Belgium, Poland - Requisition Number: R-094873 Switzerland - Requisition Number: R-094883 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 Principal Scientist, CMC Regulatory Affairs - Combination Products. This position is a hybrid role and can be located in Beerse, Belgium or Warsaw, Poland. The Principal Scientist, CMC Regulatory Affairs - Combination Products role will provide 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. Principal 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. 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 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 10% domestic or international travel 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 ma