Clinical Regulatory Writer - Various locations
- Employer
- NonStop Consulting
- Location
- France
- Salary
- Negotiable
- Closing date
- Nov 12, 2016
View more
- Sector
- Pharmaceutical, Medical Writer
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
Job Details
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
Company
Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries.
Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery. Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.
The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors.
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