Regulatory Lead

A growing consultancy is seeking an experienced Regulatory Lead to manage regulatory submissions and licensing activities for a key client. This is a remote-based role with the possibility of 1 day onsite in Cambridge or Hull, offering flexibility while delivering high-impact regulatory support across the UK, EU, and US. They are looking for this role to be an initial 6 month contract with the expectation of it becoming a permanent position. Responsibilities Prepare, author, and maintain Active Substance Master Files (ASMFs) and Drug Master Files (DMFs) in compliance with MHRA, EMA, and FDA standards. Compile and submit site licence applications, including: Manufacturer’s/Importer’s Authorisation (MIA) Wholesale Distribution Authorisation (WDA) Coordinate with cross-functional teams (QA, manufacturing, validation) to gather technical documentation. Ensure regulatory documents are accurate, complete, and submitted on schedule. Respond to regulatory authority queries and information requests. Provide regular updates to both the consultancy and client stakeholders on progress, risks, and milestones. Deliverables Submission-ready ASMFs/DMFs Complete licensing application packages Status reports, trackers, and documented authority/client correspondence Requirements Strong expertise in regulatory documentation and submissions (UK, EU & US) Proven experience with DMFs, ASMFs, and site licensing

Location: UK, GB

Posted Date: 6/13/2025