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Senior Regulatory Specialist London office based

Permanent / UK

Highly competivie

Senior Regulatory Consultant - London - office based

We are currently working with a Global CRO based in the Greater London area who are looking to boost their regulatory team with an experience regulatory professional with a rounded experience within regulatory affairs. The company offers fantastic benefits including one of the best bonus schemes in the industry and a highly competitive basic salary.

Role responsibilities:

  • Experience of marketing regulatory applications (MAA, BLA, NDA)
  • Experience of preparation and review of variation applications and renewals and Scientific Advice briefing documents.
  • Have experience of the following areas of regulatory affairs: CMC, Pre-clinical, and Clinical Project Execution
  • Working within a team environment with the experience of working independently when required
  • Strong leadership abilities with the ability to develop relationships with internal and external partners.
  • Converse effectively with external partners, and collaborate effectively with these teams and regulatory agencies.
  • Develop processes/tools to underpin effective information management in relation to regulatory policy topics, and to provide regular assessment of external regulatory change and give concise communication on its internal application.
  • Take responsibility for assigned regulatory projects; ensure the quality of submitted documentation in line with statutory requirements

Requirements:

  • Bachelors degree (or higher) in a relevant discipline
  • At least 10 years' experience in pharmaceutical regulatory activities
  • Experience of managing major projects.
  • You will need a sound knowledge of global drug development processes
  • You will need a sound knowledge of global drug marketing processes
  • Excellent communication skills with proven influencing and negotiation abilities.
  • Working within a global organization with cross-functional teams EU and Global level.

 

Key words: MAA, BLA, NDA, CMC, Pre-clinical, Clinical, EMEA, MHRA, FDA, Regulatory affairs, Management, Degree, CRO, Pharmaceutical,

 

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email info@life-science.co.uk. We regard all communication and correspondence as confidential. Full job descriptions are available on request.

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Resourcing Life Science is a specialist recruitment agency, providing career advice and employment opportunities within the Pharmaceutical, Biotechnology, Medical Devices and Clinical Research industries across the globe.

Contact

info@life-science.co.uk

0044 (0) 207 421 0000

0049 152 1164 1635

Resourcing Life Science Ltd.
Clerkenwell Workshops,
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