Wednesday, December 30, 2015

Regulatory Affairs Manager New Products





Pharmaceuticals Regulatory Affairs Manager New Products– London


Opportunity:


This is a brand new role that has been created due to expansion. My client a growing pharmaceutical manufacturing company based around the Central London area is looking for a Regulatory Affairs Manager New Products to identify and evaluate new pharmaceutical product opportunities, and ensure the effective completion of regulatory requirements in order to successfully secure Marketing Authorizations for approved new drug products.


Duties and responsibilities include:


  • Evaluating new drug development projects.

  • Preparing regulatory submission strategies and identifying timelines for all new pharmaceutical drug product development projects.

  • Preparation and submission of regulatory applications for all new pharmaceutical drug products projects, including in-licensing, new product developments and registering existing products into new markets.

  • Point of contact for all regulatory queries in relation to Strategic Development group activities, including RAMA searches.

  • Direct communication with regulatory authorities to facilitate productive dialogue on all new drug product submissions and other relevant issues.

This is a full time permanent role based in London with a great salary between £40,000 – £50,000 per annum and benefits such as holidays, pension, bonus, healthcare and much more.


Skills:


To apply for the role of Regulatory Affairs Manager New Products you will be degree qualified with significant pharmaceutical regulatory affairs experience ideally with generics drug products supporting new pharmaceutical drug development submissions and in-licensing of dossiers as well as experience in preparing CTD dossiers.


You will have a broad understanding of regulatory requirements and idiosyncrasies in multiple markets.


How to Apply:


To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat.


If this sounds like the role for you or a colleague then please don’t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information.


For a list of our current vacancies, please visit www.qualitystart.co.uk


If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.


Quality Start are acting as a specialist recruitment consultancy for this role.



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