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Job Details

R E G U L A T O R Y *** GREAT OPP, lead a mAb into MAA now in pre-sub *** Unique 1st in Class * EU & Int’l role * Dir or AD grade * UK M4 or Europe

Company: Advanced Regulatory (UK & Europe)
Location: M4 West OR Europe
Reference: MGADV / 32000 /51A
Closing Date: 02 Dec 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

This is a very unique role, because the starting point of this position to move straight in to leading the MAA preparation and submission, now completing Phase 3 trials (2 reported positively), for a First in Class molecule, in a set of indications where there has been no new products in over 10 years ...

Requirements:

R E G U L A T O R Y *** GREAT opportunity, you will lead a NME (mAb) into MAA in pre-sub now *** Fairly unique opportunity 1st in Class *** EU & Int’l role *** RA Director or AD *** UK M4 Corridor or Europe-base

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This is a very unique role, because the starting point of this position to move straight in to leading the MAA preparation and submission, now completing Phase 3 trials (2 reported positively), for a First in Class molecule, in a set of indications where there has been no new products in over 10 years.

The role sits in a global strategic project management group, which owns the PL and has US and all Core Markets including the EU, and reports to a Senior Director who is a highly-experienced biotechnology patient access lead, who will assist you in developing the filing plan, and devloping the complex narrative for high visibility decision-making.

You will have accountability for the EU strategy 1st waive and also for filing in China and Brazil, as well as other countries (2nd and 3rd waive) plus a new indication currently in development.

We are seeking someone who is highly motivated, you will know who you are, has experience in leading MAAs in Europe starting as RA Project Manager supporting a Sr Director and more recently with you as the EU RL. This could be line extension new indications or a first MAA. You will exhibit strong influencing and communication skills combined with a strong knowledge of EU MAAs under the Centralised procedure. You will interface directly with senior stakeholders, including senior executives on the management committee, as well as with commercial and development partners, as clinical, regulatory and access strategies are a shared conversational space, ie, mutually dependant.

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You will be willing to live / work in Mainland Europe OR West of London, Middlesex, Bucks, Berks, West Surrey area. Relocation is offered for both locations. Both locations come with an excellent stock package, bonus, car, health and pension. House purchase relocation is on offer for the right candidate.

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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.  You can call +447918679405 evensings and Saturday mornings.
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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: EU RL, Regulatory Lead, EU Regulatory Lead, RA Director, Regulatory Director, Regulatory Associate Director, 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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