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Job Details

R E G U L A T O R Y CMC NCEs *** TEAM Director *** Full relocation to Brussels *** Global Role *** Tax Reduction *** Private Schooling if required

Company: Advanced Regulatory (UK & Europe)
Location:
Reference: MGADV / 13005 / A
Closing Date: 11 Feb 17
Type: Full Time
Salary (£): On Application
Benefits: On Application

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Job Summary:

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.

Requirements:

R E G U L A T O R Y  CMC NCEs *** TEAM Director *** Full relocation to Brussels *** Global Role *** Tax Reduction *** Private Schooling if required

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My client is a global head of RA CMC, has this new role exclusive to Advanced, and has specific accountabilities for any small molecule (NCEs) in development or lifecycle, through a team of 5 FTEs based in site and in the regions.

  • Global role, including the US, but the client will accept someone with RA CMC in the EU and International OR US and international experiences
  • Covers both IMPs and Marketed products in all markets, through your team
  • Comes with 5 direct reports, and reports to a highly capable individual who is very focused in developing the value stream
  • Factors for success include innovating and finding creative solutions (with integrity), collaboration with development and commercial for supporting new market entry (esp. China and Brazil) and new dosage forms as well as rollout of NCEs (1 under way, 1 in development)
  • The role is for a Director level individual with the capabilities to grow within role as well as develop greater performance by developing the individuals in the team, their visibility to the business and the value they provide in the RA sub teams, with Tech Ops, and Product Teams
  • Oversight, acting as a senior level individual with the major stakeholders in the business, research and development, commercial, supply chain, QA and the regions / affiliates.

This role is first and foremost about keeping oversight for the global CMC small molecule workstreams, for regulatory CMC, for IMPs and Marketed Products, which includes major brands, generating close to 1B USD, as well as for smaller products, and those in development.

You will be involved with your team, to provide review, support, advice and direction without micro managtement, and will keep a good 360 view around each and any of the workstreams, as well as by collaborating with the stakeholders to ensure plans, issues and challenges are identified and addressed.

You will have a strong background in Regulatory CMC RA for small molecule, have experience of managing direct reports (could be a mix of contract and permanent) as well as a vision for how regulatory and Regs CMC can deliver for the business, this passion will be one of your drivers.

You will have worked ideally on global project teams, in your formative years or current role, and have experiences of taking NCEs through submission in at least one major ICH region, ideally the EU but this could include the US, or Asia Pacific. You will be taking over from an individual who is moving internally, so although this role is urgent, the individual will be around to provide you with the assistance necessary to have a smooth transition and a successful year.

_______________________________________________________________________________________

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 CMC, CMC regulatory, CMC Reg Affairs, RA CMC Jobs, CMC Jobs, Regulatory Director, RA Director, Regulatory Affairs CMC Director.

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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