Expiry Date: 06-11-2020
Category Regulatory Affairs
Job Type: Full Time
Windsor and Maidenhead
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 press the red ''Apply'' button or contact me, Theo Moore, on +442078013384 / +447918195166 to find out more about this role and other possibilities.
We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380.
GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.