Associate Director CMC Regulatory Affairs - London - CMC lead for NCE Development

Reference: TM10476

Expiry Date: 04-02-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Greater London
United Kingdom

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Job Description

Associate Director CMC Regulatory Affairs – London - CMC lead NCE Development

My global Pharmaceutical client has been described as a successful, forward-looking global player, where your career will continue to flourish. Although fairly new to the UK, they have been established in the US and other regions for over 50 years and currently have around 25NME’s in development, and for the last 15 years they have been steadily growing and developing their European Head Office based in central London, where their talented, diverse and driven teams work collaboratively to bring their pipeline of innovative medicines to market. 

My client has a culture which is focused on commitment and honesty and they have an exciting future. It would be fair to say they have the spirit of a start-up (The London based EU HQ currently sits at just over 100 people but is rapidly growing), but the organization is well established globally. Successful submissions here, are a big deal, as everyone in the EU office will have been actively involved, as it’s a flat structure that nurtures responsibility and autonomy, with most of your EU R&D colleague’s in the same building.

What’s good about this role?

This role is a great match for those that want to take full control and steer and lead their own projects, in a hands-on way for indications across all stages of early and late stage development. My client is seeking someone with experience of providing strategic RA CMC input, who is ready to lead on their projects and roll up their sleeves when necessary. You will need to be autonomous as you will potentially be involved in various projects through  various stages of the development lifecycle from FTIH to initial MAA. So Post Approval experience/expertise is not really required but we are looking for a versatile person, with strong development experience as your project activities will range from Phase 1 IMPDs to PIPs to preparation and attendance/leadership of scientific advice meetings to preparation and submission of MAAs.

My client is looking for someone enthusiastic, positive, and proactive with a determination to succeed who enjoys leading or working as part of a team but is also happy to work alone in a focused manner. The role is based in Central London, easily commutable from most of the mainline train stations such as Liverpool Street, Victoria, Kings Cross or Waterloo.

The salary and package is extremely competitive and is rated as exceptional and includes a high basic salary for AD level roles, plus Car Allowance, plus Bonus, plus 9% Pension employer contribution, over 30 days holiday plus bank holidays, Life insurance and PMI (family included).

The Role:

  • EU CMC-RA representative on global regulatory subteams, CMC development teams and RA/QA liaison team advising on regulatory CMC issues;
  • Provide regulatory CMC strategy for global development products for a mixedportfolio;
  • Responsible for authoring, reviewing and responding to questions on CMC aspects of IMPDs, PIPs, Module 3 leafs for MAA and briefing books for EU CMC scientific advice;
  • Regular interactions and negotiations with Health Authorities.

Experience needed:

  • A strong background in Regulatory Affairs CMC, with a number of achievements/submissions for products in development, with ideally knowledge/expedience in authoring IMPDs and being well versed in preparing for and attending scientific advice meetings.

This is a great role for those that like to work in the development space and provide full RA CMC leadership, guidance and strategic input for their projects!


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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