Cmc regulatory manager

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