Associate Director Regulatory Affairs Europe – Full Lifecycle, London

Reference: OLI105701R

Expiry Date: 14-11-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
London
Greater London
United Kingdom

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Job Description

We are hiring for an Associate Director Regulatory Affairs to join a growing, international pharmaceutical company based in Central London.

If you are looking for an existing professional challenge, that would give you the opportunity to grow alongside an expanding, mid-size pharmaceutical company with more than 100 years of history, then this role may be the one for you. The role is 60% in regulatory development, leading an early and a late stage asset through CTAs and filing, and 40% post-approval, leading the expansion of a newly approved product.

The role is EU focused and our client is looking for a regulatory professional with EU experience in both development and post-marketing European procedures. This is with a profitable and growing, R&D based company with flat structure and relaxed culture, where the whole regulatory team is on the same floor in their European HQ in London. You will be highly visible and supported by the leadership here. You will get responsibility early on to make a real difference, as long as you embrace to be challenged and developed professionally by experienced regulatory leaders who will back you along the way.

You will consider this role if:

  • You have at least 7 years in Regulatory Affairs regional (EU) or global strategy experience, strategic mindset and the ability to lead projects and create innovative regulatory strategies
  • You have a proven track record of leading or supporting major Health Authority interactions and submissions in either early or late phase as well as filing and post-approval.

AND

  • You are working in a pharmaceutical company where promotions are difficult and want to advance through the grades, in an organization which is merit-based and likes to promote people internally
  • You want to be rewarded for and accountable for your deliverables, reaching the key milestones, and this being acknowledged by the line management (who are superb here). The focus in this company is on empowerment and autonomy
  • You love what you do, but would prefer to have some evening time for yourself or family, without compromising on your wish to still be in a company known for its innovation and for having a decent pipeline, but not a US driven one
  • You have examined the working life of a GRL and know this means long hours, you would prefer an EU role with peaks and troughs, not constantly high plateaus!
  • You like having accountability for the EU, enjoying the visibility of taking NMEs from early and late phase to filing, and leading the MAA and Extensions/Label Expansions directly to the EMA.

Packages & Benefits

The package include a very competitive basic salary, a double digit bonus and decent stock plan as well as Car allowance. There is flexibility around start and finish times, 35 hour week as well as 25 days paid holiday, plus Christmas and New Year time off.

Interested in the above? I look forward to hearing from you in confidence!

 

To apply for this role, please press the red “Apply for position” button, or contact me Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore 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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