... quality guidelines and how to apply them. CMC/QualityEstablish CMC-regulatory strategy for projects/products. Lead ... affiliates/distributors in new markets on CMC-regulatory issues. DevelopmentEvaluate CMC-regulatory processes and propose solutions ... More Details
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... quality guidelines and how to apply them. CMC/Quality Establish CMC-regulatory strategy for projects/products. Lead ... affiliates/distributors in new markets on CMC-regulatory issues. Development Evaluate CMC-regulatory processes and propose solutions ... More Details
... of high-quality chemistry, manufacturing, and controls (CMC) documentation to support original MAAs, variations, and ... skills and interpersonal skills. Desirable Regulatory Affairs CMC experience of investigational and commercial products. Relevant ... More Details
... submission, review and approval of global CMC applications. Represent Global CMC Regulatory, on Regulatory Networks and ... processes. Experience and working knowledge of worldwide CMC regulatory requirements. Experience managaning and directing multiple ... More Details
... and external service providers/vendors. Responsibilities: Management of CMC projects to ensure operational milestones are delivered in ... of GMP operations at identified new facilities Lead CMC communications for operational activity to internal stakeholders ... More Details
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... with minimal unanticipated questions. Ensure all appropriate CMC regulatory aspects to support license maintenance and change ... in the pharmaceutical industry Experience with worldwide CMC regulatory requirements Preferred Qualifications: If you have ... More Details
... for the strategy development and creation of CMC submission documents from early phase clinical submissions ... related scientific discipline. Chemistry, Manufacturing and Controls (CMC) regulatory affairs or chemical and pharmaceutical development experience ... More Details
... multiple projects and stakeholder's satisfaction.- Provide regulatory CMC advice to project members. - Lead preparation ... development projects towards submission and approval.- Providing CMC support on established products including growth market ... More Details
... Clinical are recruiting for a Senior Manager, Regulatory CMC for a permanent role with a well-established ... , Hertfordshire. Senior Manager, CMC Role: To lead Regulatory CMC activities and to provide Regulatory CMC expertise to multiple global ... More Details
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Role: Senior Regulatory Affairs Associate - CMC Location: Uxbridge Employment: 12 months contract Reference ... this role you will lead compilation of CMC regulatory packages for submission and may be ... Excellent English language skills Must have CMC experience More Details
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