Expiry Date: 27-09-2019
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Associate Director Regulatory Affairs CMC ** London ** Lead projects in development
We have an opportunity for a versatile Regulatory Professional, with full lifecycle experience, to become an Associate Director Regulatory Affairs CMC and lead small molecule projects in development with a growing pharmaceutical company based in central London.
This is a permanent role, easily commutable from West and North London as well as parts of Hertfordshire and Essex. The role comes with a competitive salary, short- and long-term incentive programs as well as car allowance, some flexibility to work from home and a 35-hour working week.
Our client is a growing pharmaceutical company that is on the forefront of innovation backed by its global parent company, but operating fairly independently as a stand-alone pharmaceutical company. The structure feels flat and the whole Regulatory team sits together. Decisions are quick and there is high level empowerment and autonomy within the team. You need to be independent, calm, cool and collective, prepared to give guidance to team members and technical teams as the culture here is one of doing things properly and not hurrying them. You will need to be flexible on case-by-case bases and have a logical, analytical, evidence-based approach to leasing with the different teams.
Our client needs someone who wants to be and needs to be very hands-on – leading and owning projects, authoring IMPDs from scratch, taking the lead for products in Ph1, Ph2, co-authoring, giving strategic input and also supporting MAAs or post approval submission for some of the already marketed products.
This role will not manage people and will not become a people-management role in the near future. This is about project management, rolling your sleeves and getting involved in different projects at various stages of the product lifecycle – gaining and consolidating your experience along the way.
For this role it is essential that you have IMPD authoring experience, and have authored and supported MAAs in the EU. PIP experience and Scientific advice will be an asset.
We look forward to hearing from you.
To apply for this role, please press the red “Apply for position” button, or contact 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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