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: 06-11-2019

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Windsor
Windsor and Maidenhead
United Kingdom

Apply for position

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.

Package

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 theo@advtalent.com and I will respond to you by return.

Key Words / Keywords: Regulatory Affairs, RA, RA Jobs, Regulatory Affairs Jobs, RA Manager, RA CMC, CMC Roles, CMC London, Jobs in UK, UK Jobs, Regulatory Jobs, Regulatory, Biopharmaceutical Jobs, Biopharma Roles, Biotechnology, Biopharma, Pharmaceutical, Pharma, Bio-pharmaceutical, Bio-technology, United Kingdom, Global Regulatory Affairs, CMC Bio, CMC Bio jobs, CMC Bio RA roles, Line Manager roles in regulatory, CMC Manager, Snr Manager Jobs.