Regulatory Affairs CMC Snr Manager - Use your EU Experience to gain GRL status

Reference: TM10486A

Expiry Date: 14-12-2020

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
London
Greater London
United Kingdom

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Job Description

Regulatory Affairs CMC Snr Manager - Use your EU exp. to gain GRL status

This is a rare opportunity where you can grow and develop to be the lead for both EU and US markets, for small and/or large molecules in a medium sized organization with a structure that likes to give regulatory staff the opportunity to reach their potential.

This role is focused on taking the lead for strategic development activities initially in the EU but with growth opportunities to also work on US projects.

Location: Windsor, South-East, commutable from Maidenhead, Reading, Slough, Uxbridge, High Wycombe and London. Great transport links and close to a mainline train station, with company bus service from station to the offices.

This rapidly expanding organization has a reputation for giving opportunities to those who show promise and ambition and it’s a fast paced environment where you stand a greater chance of being noticed for your contribution than in a larger organization where you can easily become pigeon holed.   You can easily interact with upper management and expect to be given the opportunity to be involved in multiple projects, where you will gain more experience.

The regulatory department here is part of the Global RA department, so expect to be involved in key strategic decisions for all major markets. You will be encouraged to become a strong performer, and as a result you will receive faster promotions and regular pay increases.

The culture here is based around creating an environment where people want to work, where people feel empowered to be a success and where people are moving in the direction that they want. The focus here is on better team work and co-operation with a focus on getting work done and less politics.

In the short-term you will be working on clinical development projects in Phases 2 and 3 as the Regulatory CMC lead, guiding these projects through to MAA. In the longer term you will have the opportunity to work in a global role as a GRL or move into early development position and gain experience across the full project lifecycle.

Role / Responsibilities:

  • Defining strategy, planning and preparation of regional specific CMC submission documentation for assigned geographical regions and contributing to the preparation of global submission documentation to deliver timely approvals to meet business needs.
  • Representing CMC on Global Regulatory Affairs Teams, for assigned projects/products.
  • Leading and/or providing regulatory CMC input to all Health Authorities (HA) interactions on CMC.
  • Leading or providing input to internal regulatory business initiatives and cross functional work streams as assigned.

The package for this role is extremely generous and includes a top level salary, company car or car allowance, bonus of up to 15% per annum, lucrative stock plan (approx. 10-20k per year) with a high level benefits package which includes a-grade health insurance, strong pension, dental, death in service, options to work from home.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 or Oli Dimitrov on +44 (0)207 801 3388 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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