Senior Principal Scientist, CMC Regulatory Affairs - Combination Products
Core
Senior scientific and regulatory subject matter expert leading complex combination product regulatory strategies, programs, and processes for pre-approval and post-approval programs.
Role type
Senior Principal Scientist, CMC Regulatory Affairs (Combination Products)
Builds
Global regulatory strategies for clinical, marketing, and lifecycle management submissions involving combination products
Domain
Healthcare / Pharmaceutical / Combination Products / Regulatory Science
Required skills
Expert interpretation of global combination product and medical device regulatory requirements, strategic oversight of submission content, regulatory risk assessment, mentoring and coaching, cross-functional leadership, external representation in regulatory forums
Preferred skills
Advanced degree in scientific, engineering, pharmaceutical, regulatory science, or related discipline
Technologies
None stated
Responsibilities
Serve as CMC Regulatory Affairs lead for complex, novel, high-risk combination product programs; Lead development of global regulatory strategies for clinical, marketing, and lifecycle management submissions; Provide strategic oversight and expert review of device and combination product-specific submission content; Lead regulatory assessments and strategic decision-making for complex manufacturing and product changes; Lead development of regulatory strategies for significant Health Authority interactions; Lead cross-functional initiatives related to regulatory process improvements and organizational capability building; Represent the company in external regulatory, industry, and scientific forums related to combination products and medical devices
Seniority
Senior Principal, hands-on IC with strategy & mentorship