Clinical Regulatory Writer - Various locations

Location
France
Salary
Negotiable
Posted
Oct 13, 2016
Closes
Nov 12, 2016
Ref
CK113120.7
Contact
Chloe Khatcherian
Organization Type
Corporate
Contract Type
Employee
Hours
Full Time

Non Stop is currently looking for a regulatory affairs specialist on behalf of a pharmaceutical group developing innovative diagnostic and therapeutic products in the field of Nuclear Medicine. As part of their development, your key tasks will be the following:

  • Write and/or review high quality preclinical and clinical sections of dossiers and responses documents for submissions with new Marketing Authorizations, variations and renewals via Centralised/Decentralised procedures.
  • Write and/or review Scientific Advice briefing documents and scientific documentation supporting clinical trial applications, such as IMPD's
  • Write and/or review other regulatory documents, such as ODDs, PIPs or similar,
  • Prepare relevant submission documents, perform and coordinate submission activities of all types of regulatory applications,
  • Provide scientific advice and early stage development strategy and project management of all regulatory requirements and show a detailed knowledge of current legislation associated with the regulatory requirements,
  • Write internal procedures in relation with Regulatory Affairs
  • Provide a regulatory surveillance in accordance with planned and on-going project

You will have the opportunity to work from one of their offices: Spain, Poland, Portugal, Italy, France, Netherlands

Profile:

The candidate has a minimum of 3 years of regulatory experience and requirements expertise in European regulatory procedures (with FDA will be an asset) with strong pre-clinical and clinical dossier writing knowledge. English fluent only.

If you are interested in this position, please contact Chloé Khatcherian on 0033 1 76 75 33 40 for further information or send your CV in word format to c.khatcherian@nonstop-recruitment.com