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Job Details

Regulatory Affairs Director (Early Phase Global Development)

Company: Advanced Regulatory (UK & Europe)
Location: West of London/M4 Corridor
Reference: TMADV / 190318A
Closing Date: 24 May 18
Type: Full Time
Salary (£): Negotiable
Benefits: Lucrative Salary + Bonus + Bar + Share Options

Job Summary:

You can grow with your molecule, and develop your skills in a way which will allow you to gain more US experience, as well as a greater understanding of global drug development -

Requirements:

Regulatory Affairs Director  - Early Phase Global Development Role!

My client is expanding, and has appointed a new global therapy lead to manage this team, who has a great deal of expertise in US and European submissions, development strategy and HA liaison. This role reports to this person. You will work on US and EU as well as AP INDs, from regulatory strategy documents which you will co-author. The role is focused on early stage molecules, supporting 4 or so groups of indications, in a company where R&D is mostly based in Europe.

You can grow with your molecule, and develop your skills in a way which will allow you to gain more US experience, as well as a greater understanding of global drug development. You will have experience and knowledge of the following and consider yourself ready for a Director role:-

  • Have co-/authored and led either Ph 1/2 NMEs for INDs or CTAs (non CMC), OR have expertise in Ph2 B or Ph 3a and have a good understanding of the drug development process
  • You will be autonomous but also be engaging with your project team, able to devise work arounds and tactics, which push your molecule forward, in a company which is committed to patient safety and has sound ethics
  • You will have prepared for HGA meetings, and may be had co-led some of these yourself, certainly in at least one major region, ie Europe or the US, other regions or nationals would be desirable
  • You want a stable role where the science is the attraction and be willing to work in true drug development environment, if you are looking for a cascade of submissions this role is not for you (see our other advertisements).

You will have 10+ years in drug development regulatory affairs and be a Life Science graduate. You will be eligible to work in the EEA. A relocation package is open to individuals both inside the UK and outside the UK. The company are located in the West of London, M4 Corridor, M40 South region, and commutable from these areas as well as Middlesex and South West London.

A car allowance, bonus and stock plan are on offer for this role. The pension scheme is better than average and the company is growing by around 10-15 per cent per annum turnover terms and approaching 30% profitability.

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If you wish to apply for this role, please send your CV with a covering note to cv@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on +44 (0)20 7801 3380.
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About Advanced

Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs.

We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com.

We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.

Keywords / Key words: Regulatory, Regulatory Affairs, Reg Affairs, RA, Regulatory jobs, RA jobs, Regulatory Affairs Jobs.

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
Suite 8 Penhurst House 352-356 Battersea Park Road London
SW11 3BY
England
Tel:  +44 (0)20 7801 3380
Fax:  +44 (0)20 7228 1188
Website:  Visit Our Web Site

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