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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
You will serve as the Pediatric Regulatory Lead for assigned products and play a key role in developing and executing regulatory strategies, plans, and objectives for pediatric development programmes across the Virology, Oncology, and Inflammation
You would be a contributor to a Global Team with collective responsibility for regulatory activities associated with global pharmacovigilance including electronic pharmacovigilance system, adverse drug experience (ADE) reports, trending reports, ADE
Develop and lead clinical biomarker strategies across Ipsen's oncology and rare disease portfolio to support critical development and portfolio decisions. Define biomarker plans to support target engagement, pharmacodynamic and mechanistic understanding,