Regulatory Knowledge Specialist
Andy Leake is recruiting for a Regulatory Knowledge Specialist to join a global, pharmaceutical company at their site based in Slough on contract basis.
Your main duties will be:
- Provide effective support, training and assistance to colleagues in order to provide suitable data stewardship and process ownership.
- Analyse, remediate and disseminate information held in regulatory databases.
- Suggest modifications to known procedures and processes to overcome issues in an effective and time-efficient manner.
Further responsibilities will include:
- Use initiative in improvising and identifying new approaches to work practices.
- Performing quality control checks and proof reading on data entered into global license tracking and Regulatory Submissions databases.
- Authoring, Reviewing and Approving documents including Validation Deliverables, SOPs, Release Notes, User Guides, Protocols, Reports and FAQs.
The ideal candidate for this role will have:
- Bachelor's Degree in a Scientific discipline.
- Good proven regulatory affairs experience in the pharmaceutical industry.
- Extensive knowledge of regional regulatory agency requirements as they relate to maintenance of product information and submission tracking.
- Extensive knowledge of registration tracking technologies, document best practices related to system usage, archiving, and tracking.
For more information or to apply for this position, please contact Andy Leake on 01438 842 966 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46699 in all correspondence.