Regulatory CMC Consultant (BBBH13252) Marburg

Aplitrak - Marburg an der Lahn - 25-01-2020 zur Vakanz  

Hobson Prior are looking for a Regulatory CMC Consultant to join a top Biotechnology organisation who specialise within Rare Diseases. This position will be on a contract basis to be remote and/or on site in Marburg.

Job Responsibilities:

  • You will be responsible for planning, coordinating, preparing and the submission of CMC variations and Type II variations, mainly for products registered under MRP.
  • Potential support of a Repeat use procedure, PSUR and briefing book finalization.
  • Potential support with filings related to Brexit.

Key Skills:

  • Effective communication skills, both written and verbal.
  • Strong organizational and problem-solving skills, with the ability to prioritize workload with limited instruction.
  • Flexibility to work independently and in teams in a global matrix organization.
  • Strong interpersonal skills with a demonstrated ability to develop collaborative, constructive and effective relationships.

Requirements:

  • Bachelor’s in science-Related Discipline or 3 years apprenticeship as Medicinal Documentation Professional or equivalent
  • Previous experience in MS Office Tools (Word, Excel. PPT & OneNote), Adobe Acrobat Pro, SharePoint* and Documentum: docNet and SSV Archiving*
  • An advanced degree in scientific discipline would be advantageous.
  • At least 3 years professional experience in Regulatory Affairs
  • Basic knowledge of drug development, or paramedical, and/or biological sciences.
  • Experience with or demonstrated ability to learn new regulatory requirements.
  • Microsoft Office, Documentum etc.
  • Fluent in English.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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