Sr Manager, Regulatory Affairs CMC, Combination Products and Device

Role: Senior Manager, CMC Regulatory Affairs – Combination Products and Device, supporting global regulatory strategies and lifecycle activities for device and combination product development and registration. Responsibilities include developing regulatory strategies, serving as the lead for combination product programs, interpreting global regulations, preparing regulatory submissions (IND/CTA, NDA/BLA/MAA), supporting agency interactions, and maintaining awareness of regulatory trends. Collaborates closely with Pharmaceutical Development & Manufacturing teams to integrate regulatory requirements into program planning and execution. Qualifications: Bachelor’s or advanced degree in life sciences or related field with 8+ years (BA), 6+ years (MA/MS/MBA), or 2+ years (PhD/ PharmD) experience in biopharma, specifically supporting development, submissions, and lifecycle management of combination products and devices. Requires working knowledge of global CMC regulatory requirements for devices and combination products, strong organization and communication skills, and ability to influence across functions. High-value: focus on combination products and devices in development or lifecycle, supporting regulatory submissions across phases, supporting global health authority interactions, and contributing to process improvements. Work setup: unspecified.