Principal Scientist, CMC Regulatory Affairs - Combination Products (1 of 2)

Overview In this role you will provide expert CMC regulatory guidance for drug-device combination products, shaping global regulatory strategies and lifecycle management. You will collaborate with cross-functional teams to address complex regulatory challenges and ensure compliant submissions across clinical, marketing, and post-approval programs. You will monitor evolving global regulations and support Health Authority interactions to enable safe, effective combination products. This position offers the opportunity to influence global regulatory execution within a leading healthcare innovator. Verantwortungsbereiche Provide regulatory expertise on global requirements for drug-device combination products and related devices Develop and execute regulatory strategies for clinical, marketing, and lifecycle submissions Review submission content for clinical trials, marketing applications, Notified Body dossiers, and design control deliverables Assess regulatory impact of manufacturing, device, and product changes globally Lead Health Authority interactions, briefing books, and responses for combination product questions Participate in cross-functional initiatives to improve regulatory processes and capability development Monitor emerging global device and combination product regulations and communicate impacts to teams Support regulatory compliance, lifecycle management, and organizational capability-building objectives Zentrale Anforderungen Bachelor’s degree in a scientific, engineering, pharmaceutical, regulatory science, or related discipline; advanced degree preferred Minimum 8 years of experience in Regulatory Affairs, Quality, and/or Product Development Experience in pharmaceutical, biotechnology, medical device, or combination product regulated environment Knowledge of regulatory, scientific, and product development principles relevant to regulated healthcare products Ability to develop regulatory strategies and collaborate across a global, matrix organization Excellent written and verbal communication skills; strong analytical and organizational skills 10% domestic or international travel Cross-functional collaboration Influencing decision-making Analytical problem-solving CMC regulatory knowledge for combination products Submissions and regulatory risk assessments Notified Body technical dossier review