Associate Director, Global Regulatory Affairs CMC Devices and Combination Products

Associate Director Of Global Regulatory Affairs Chemistry, Manufacturing, And Controls (Gra-Cmc) Devices And Combination Products

Position Summary : The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Devices and Combination Products plays a pivotal role in implementation of global CMC regulatory strategies related to Alexion's drug / device portfolio, in vitro diagnostics and clinical decision software leading to successful registration and life-cycle management of unique and technologically complex products. This role will influence complex projects and support responses to regulatory agency inquiries for Alexion's commercial and investigational products. Primary Responsibilities : Responsible for independently managing assigned CMC programs, including daily execution of plans, strategic activities, and compliance for clinical and commercial products. Lead the development, preparation and submission of the CMC dossiers, technical documentation, Notified Body submissions, 510(k)s, supplements, and renewals for commercial products, including accountability to global regulatory CMC commitments. Establish effective collaborations to ensure regulatory strategies for precision medicine, digital health and medical devices accommodate drug regulatory and submission plans including HA engagements and risk mitigations. Develop proactive regulatory strategies for global CMC product lifecycle management, with limited oversight. Independently resolve complex issues and manage regulatory risks and ambiguous situations within project teams. Investigates opportunities for regulatory innovation / promote the use of novel approaches and present CMC strategies and plans to management and appropriate core teams. Partner and work closely with key partners both internal and external to the company, providing guidance and expertise on assigned GRA-CMC device documents / projects. Participate in GMP inspections and lead GRA-CMC interactions. Propose new / revised policies and recommend standard interpretation of global regulations and industry standards. Maintain an awareness of global legislation and assess its impact on the business and product development programs. Mentor junior staff as needed. Qualifications A Bachelor's degree in relevant scientific discipline MS or Ph.D. preferred. Relevant technical experience in biopharmaceutical or related industry experience with at least 6 years of Device Regulatory experience; extensive experience should be in reviewing, authoring CMC components of medical devices, combination products, in vitro diagnostics and clinical decision software. Significant understanding of new product development process, the FDA QSR, Canadian MDR, EU MDR and IVDR. Other relevant experience with other HAs will be considered. Strong written and oral communication skills; comfortable communicating with and building relationships with numerous stakeholders in a cross functional environment. The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to : use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours