Senior Manager, CMC strategy - Homebased in UK, Poland, Spain or Germany
ICON is seeking a highly motivated Regulatory CMC professional to join their Global Regulatory Affairs team. This role involves global CMC regulatory strategy and activities, primarily focusing on the US FDA, and is responsible for strategic guidance, submissions, and ensuring compliance with regulatory requirements across all phases of drug development, market launch, and product lifecycle. The position requires a strong understanding of global regulatory environments and the ability to navigate complex FDA processes.RequirementsDefine, coordinate and implement global CMC regulatory strategies for product specific development and life-cycle activities.Provide proactive strategic guidance on global regulatory and manufacturing sub-teams.Negotiate with regulatory authorities during the development process to ensure submission acceptance.Manage the CMC regulatory strategy of high quality and compliant regulatory CMC documentation.Facilitate communication of regulatory information and provide regulatory input.Identify and recommend effective CMC regulatory strategies.BenefitsAnnual leave entitlementsHealth insuranceRetirement planning offeringsEmployee Assistance ProgrammeLife assuranceFlexible country-specific optional benefitsOriginally posted on Himalayas
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