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Own EU regulatory strategy for assigned programs from First-in-Human through pivotal development and marketing authorization; Serve as primary EU regulatory contact for cross-functional teams and provide clear, actionable regulatory guidance while
You'll be the primary regulatory CMC voice on cross-functional matrix teams, covering everything from early clinical trial applications through to new marketing authorizations, post-approval changes, and full lifecycle management. That means you won't
Lead the design and execution of clinical pharmacology strategies and corresponding studies across multiple programs. Develop innovative and meaningful clinical pharmacology approaches that accelerate and de-risk drug development Define dose selection,
Act as the Safety Science representative in the Medical Development Team (MDT) and ensure integration of safety into product development and lifecycle decisions; Provide clinical safety input into study design, conduct, analysis and interpretation,
Responsible for providing lead medical input and expertise to clinical development programs conducted for Therapeutic Dermatology products. Acting on the responsibility, the Head of Medical Experts, Therapeutic Dermatology, secures that clinical