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CMC Regulatory Manager

Apsida Life Science

LeicesterFull-timeMid LevelOn-site

Job Description

Title: CMC Manager Location: United Kingdom Duration: 12-month contract (100% attendance) Company Overview Apsida Life Science is currently partnering with a clinical-stage biotechnology company that is developing a potent, selective, and orally bioavailable small-molecule. Responsibilities Support overall CMC program execution for Phase 3 readiness and commercial planning activities Develop and maintain integrated CMC timelines, project plans, risk registers, and action trackers Coordinate cross-functional meetings with internal stakeholders and external partners Track project deliverables and ensure alignment with regulatory and clinical milestones Prepare meeting agendas, minutes, and follow-up actions for governance and technical meetings Support inspection readiness and due diligence activities as needed Budget & Financial Tracking Manage and track CMC-related budgets, purchase orders, invoices, and accruals Monitor spending against forecasts and support annual budgeting exercises Coordinate with Finance and external vendors to ensure timely processing of contracts and invoices Assist with vendor selection and management activities Clinical Supply & Logistics Coordinate clinical supply manufacturing schedules, supply of raw materials and shipping logistics Manage shipment planning for drug substance, drug product, reference standards, and critical materials Work with Supply Chain and Clinical Operations to support global clinical trial requirements and commercial supply planning Ensure appropriate documentation for import/export, temperature monitoring, chain of custody, and GMP compliance Support inventory tracking and reconciliation activities Qualifications Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline 5+ years of experience in CMC, Technical Operations, Manufacturing, Supply Chain, or Pharmaceutical Project Management Experience supporting clinical-stage small molecules Demonstrated experience managing external CDMOs and cross-functional projects Strong organisational and project management skills with the ability to manage multiple priorities simultaneously Familiarity with GMP regulations and pharmaceutical development processes Excellent communication and interpersonal skills Proficiency with Microsoft Office, project management tools, and budget tracking systems If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science: www.apsida.co.uk +44 (0) 744 134 2281 Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective and trusted recruitment service that puts the candidate journey at the heart of the recruitment process

Posted 2 days ago

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