Clinical Regulatory Writer - Various locations
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
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 firstname.lastname@example.org