CMC Regulatory Manager / Senior Manager ** Early to late, IMPDs, to MAA/BLA authoring ** Develop into a GRL for CMC in time, Pure Dvlpt role

Reference: MG109871

Expiry Date: 06-02-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Windsor and Maidenhead
United Kingdom

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Job Description

The company is a successful bio-/pharmaceutical company, spending <>20% of T/O on R&D and is growing by around 10% in sales per year. The team support all NMEs (mostly NBEs) from Ph 1 to Ph 3, first MAA/BLA and injector, before handing it over to another team for lifecycle management.

You will see yourself as someone who will in time, develop into a strategy leading role, but know equally that this requires learning more and gaining more experience in the preparation and submission of major submissions.

This is a pure development role, so you will be in the right place to gain this experience, and will join a couple of projects, including at least 1 major programme going into Phase 3. You will be an individual who has good authoring skills, so taking expert reports and source documents from the CMC sub-teams, and authoring M2.x/M3 into MAA/BLA submissions, under the guidance of a highly experienced people manager, an ex-placement of ours, who will bring your skills on and help you gain that depth of experience more senior CMC RA leaders and Directors offer.


The company are offering a competitive package, some home / work flexibility, plus a bonus. The role is based within easy commute of West London, Berkshire, Middlesex, and South Bucks. There is parking and a curtesy bus from the station (around 5 mins).

To apply, please contact me, Theo Moore, on +442078013384 / +447918195166 to find out more about this role, alternatively, send a full CV to and I will respond to you by return.

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