Regulatory Director - EU Regulatory RA Strategy (Cambs)

Reference: MG130820RA

Expiry Date: 12-12-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Cambridge
Cambridgeshire
United Kingdom

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Job Description

Regulatory Director - EU Regulatory RA Strategy (Cambs)

This role is within easy commute of the South Cambridgeshire / Hertfordshire borders.

I am working with a global head, for a smaller innovator R&D company, in rare and orphan diseases, who I have known for more than 10 years, and has been both a pleasant customer and successful past candidate. They are highly pragmatic, and helpful, and are seeking someone who can partner on the pipeline, and lead, focusing on EU strategy for 2-3 NMEs in development (as EMA Liaison) as well as contribute to global thinking, the global clinical and regulatory strategy and planning.

You will like this role if:-

  • You work for an American Biotech and might find gaining that elusive Director or even Associate Director grade annoying – alternatively, you might be working in a company which does not have hierarchical grading as such and feel you are ready to step into a Regulatory Strategy Leading role!
  • You want to work in a company which can offer a great deal of flexibility around home working, for the right personality, and you might not prefer calling West Coast anymore, as my clients US offices are in East Coast; in any case if you relate to these messages we would like to hear from you!
  • You want to help shape a new regulatory department, which in time will grow, in a role which will focus more on regulatory in development phases than lifecycle management
  • You want to be visible for your efforts, in a company which is sized for you to be seen for your efforts, and a leadership team which is accessible
  • You have managed clinical line extensions, or assisted / or co-led on a MAA submission or review process and want more responsibility for overall EU thinking and strategy, in a company where the Head of RA, will support you in your growth
  • You have managed multiple endpoint submissions in clinical phases and have a strong understanding of the Cardio-Vascular, NASH, Renal, or Liver, or Genetic disorders and want to lever this in your next role!

Note on Covid!

This company as I mentioned are a smaller innovator, they are building a close knit team in their Cambridge offices but, as Covid is here, are working mostly remotely. They have the digital hiring ready to help you interview and join remotely, and when the time is right, they will convene office working - there is a lot of flexibility here, for working from home post Covid!

Your Experience

You will have co-/ led MAAs or Label Extensions / Line Extensions, supporting / reviewed or filed CTAs, prepared SA meetings. Alternatively, you will have worked in a CRO consulting team, on ODD development or in general consulting (non CMC), and now want to work in-house.

Package & Benefits

The role comes with a competitive package, including higher level bonus of 25%, a near or over 6 figure salary, plus quicker vesting stock plan. The company will support some 2020 bonus buyout for the right candidate!

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 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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