CK Group is recruiting for a Regulatory Affairs Associate to join a world leading pharmaceutical company at their site based in Uxbridge on a 12 month contract basis.
The Regulatory Affairs Associate with be joining the EU team working within the Oncology therapeutic area. The main purpose of the role will be to:
-Assist in the creation and submission of regulatory documents.
-Preparing and submitting CTAs
-Coordinating response preparation.
-Provide and maintain CTA/MA documentation support in collaboration with Regional Regulatory Lead and ensure compliance via timely submissions to regulatory agencies.
-Act as appropriate participate in supporting the execution of regulatory strategy and create and maintain product regulatory history documents, appropriately archiving all regulatory documents and agency communications.
-Assisting in the preparation of post authorisation submissions. For example, variation applications, RTQs for centrally authorised products, or purely national products.
Further responsibilities will include:
-Providing primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) and preparing regulatory packages and cross-reference letters to support investigator initiated studies.
-Supporting process improvement initiatives, standards development, and metrics and supporting the development and execution of team goals.
-Providing regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level or above in life science or a related field with experience of working within Regulatory Affairs, particularly with Clinical Trial Applications as well as having an understanding of the drug development process.
-Proficient in Microsoft Office - Outlook, Word, PowerPoint and Excel.
-Excellent communication and organisational skills and the ability to work to tight deadlines.
-Be confident writing cover letters, application forms and help/assist in pulling together responses with the support of a cross-functional team.
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 KA42731 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Jennifer Woolley
- Phone: 01438 743047
- Reference: KA42731
- Posted: 10th July 2018
- Expires: 7th August 2018