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Senior regulatory cmc specialist

Reading (Berkshire)
Walker Cole International
Posted: 14 June
Offer description

Walker Cole International are currently searching for a Senior Regulatory CMC Specialist to join an exciting global consumer healthcare business with a portfolio of household name brands. This is an opportunity for somebody with mentoring experience or project & people management to progress their career. Based in Southeast England. Your responsibilities as a Senior Regulatory CMC Specialist: Oversee the authoring and reviewing of CMC documents, coordination and management of global submissions. Act as global/regional CMC representative within cross-functional team projects. Lead the preparation of CMC information for submission to global regulatory agencies. Line management. As a Senior Regulatory CMC Specialist, you will have: Expertise in Regulatory CMC strategy and authoring, module III. Knowledge in the regulatory requirements of post approval changes for global markets including ICH guidance Knowledge in handling post approval changes of Solid Oral, nasal sprays and other Dosage. Mentoring or line management experience. CMC // Regulatory // Senior Specialist // Post approval // Senior Regulatory CMC Specialist // Regulatory CMC // Module 3 // OTC // Consumer Healthcare

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