Regulatory Senior Manager CMC

£0.00 - £65000.00 per annum
  1. Permanent
  2. Senior/Director & VP, CMC
  3. Germany
Frankfurt am Main, Hessen
Posting date: 17 Jul 2019
RA.RE.24369_1563375345

An international pharmaceutical company is advertising a vacancy for a Regulatory Senior Manager CMC, based in their office in Germany. This organisation provides early strategic planning activities and non-clinical requirements to clinical development, through regulatory submission processes to market approval and product-maintenance post-launch activities. This is an exciting opportunity to work with this leading establishment and significantly bolster a career in the regulatory field.

Job Responsibilities:

  • Planning and implementation of approval procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as of life cycle management procedures (variations, renewals, MAH transfer etc.) worldwide.
  • Communicating in the project team, with customers, local partners and authorities in an international context.
  • Revising approval documents and text management (labeling management).

Skills and Requirements:

  • A degree in pharmacy, medicine or other life sciences.
  • At least 3 years of professional experience in marketing authorization with a focus on the EU or non-EU marketing authorization procedures and ideally have experience in launch management (DE), labeling management, and clinical trial applications (CTA), as well as marketing authorization procedures in non-EU countries.
  • Sound knowledge of current pharmaceutical and regulatory requirements (EU).
  • You have experience in project management, you are multi-tasking capable, enjoy consulting.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Robert Esposito at +44 203 761 5702 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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