CMC Regulatory Affairs Officer

3 days left

Recruiter
Anonymous
Location
Nottingham
Salary
25000.00 - 33000.00 GBP Annual + GBP25000 - GBP33000/annum
Posted
26 Aug 2017
Expires
23 Sep 2017
Contract Type
Permanent
My client, a very successful pharmaceutical business based in the Midlands are currently recruiting for a Regulatory affairs CMC Officer to be accountable for successful regulatory documentation and submission. The Regulatory affairs CMC Officer will be responsible for maintaining and ensuring that the dossiers meet the regulatory body requirements.

Role/Responsibilities;
*Prepare and submit CMC applications in a timely manner to regulatory bodies.
*Previous experience of Technical file writing of CMC Documentation
*Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
*Maintain up-to-date records and documentation in relation to Marketing Authorisations.
*Assist in preparation of procedures for relevant regulatory activities, and in preparation and review of procedures for other areas.

Personal specification
*Ideally a scientific degree such as Pharmacy/Chemistry degree
*2-3 years Regulatory Affairs experience within a pharmaceutical organisation
*Experience in authoring dossiers is essential
*Previous experience to eCTD format and electronic submission gateways is preferable.

If you believe you hold the relevant background experience and looking for a fantastic opportunity to join a growing and successful Pharmaceutical company and in return they are offering a competitive package, fantastic benefits

The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency