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