Company: Advanced Regulatory (UK & Europe)
Location: Call for the actual location
Reference: MGADV / 200123 /A
Closing Date: 07 Nov 16
Type: Full Time
Salary (£): On Application
Benefits: On Application
We are working to back fill a role due to a promotion internally, with our client, which is a biopharmaceutical company with sites in the M4 Corridor and mainland Europe. The position is to deliver the complete lifecycle strategies for a blockbuster drug including new country subs (incl China) ... call Theo Moore or Matt Greig in the London office on +44 (0)20 7801 3380.
Regulatory CMC Leader, BIO mAb lead a team of 6-8 FTEs for US, EU and ROW Submissions
We are working to back fill a role due to a promotion internally, with our client, which is a biopharmaceutical company with sites in the M4 Corridor. The positon is to deliver the complete lifecycle strategies for a blockbuster drug including new country subs (incl China), new manufacturing lines incl a site transfer, combination device registrations (AIs) and through your team all and any DP or DS changes to all markets (so there is complexity).
The team is spread over 2 continents and services all markets and this role in matrix reports to 2 GRLs in therapy regulatory as well as in terms of the department, an experienced CMC RA Lead who has worked on both this molecule and another blockbuster drug previously – ergo you have a strong technical leader who knows how to bring you through your next steps of development, who embodies an empowering management style.
You will be accountable for the product lifecycle for CMC for all markets including motivating and supporting your own team, in a flat matrix where the work stream is shared between the matrix reports. The company have this product to work on but have a strong pipeline with a new registration for a NME running in parallel, so this is a period of expansion for regulatory CMC and their counterparts in global technical operations.
We are seeking an individual who has strong leadership at matrix level and with stakeholders, proven expertise in regulatory submissions in both drug product and manufacturing changes hence drug substance as well as abilities with both European and ROW or US and EU as a minimum.
If you wish to apply for this role, please send your CV with a covering note to email@example.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.
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 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.
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