job details for:
Regulatory Affairs - Regulatory Affairs Associate Jobs

Regulatory Affairs - Regulatory Affairs Associate Jobs (Job Ref: WR/JOBS/26148-12326)

Job Description :

Flame Pharma - Clinical Research - Regulatory Associate Job - Cambridge, UK

Salary: up to 22k

Flame Pharma is working alongside a leading Contract research organisation in their search for a Regulator Associate to provide basic regulatory advice and facilitate preparation, planning and coordination of regulatory documentation from provision from a client to timely submission of final document back to client or relevant Regulatory Authorities & to liaise with internal and external clients in the tracking and status update of project plans.

The Role:

Reporting to the Regulatory Affairs Manager, the Regualtory Associate will provide basic project specific regulatory services and co-ordination of these projects under guidance, liaise with internal and external clients in the tracking and status update of project plans & under guidance, review and prepare regulatory submissions in EMEA and Asia Pacific. They will assist in the preparation of regulatory affairs documentation which will include, on the job and external learning of regulatory documentation construction, manually and with IT tools, developing forms and standard document templates for regulatory documents, proactively plan the availability and preparation of the documentation with the CRAM to ensure draft and final documents are provided to agreed standards and timelines & proactively set up appropriate styles and formats for documents (masters and templates). The successful applicant will also co-ordinate version control of all documents and labelling texts, the out-sourcing of any documentation, printing, copying and binding etc & provide regulatory advisory and training service for regulatory affairs in the company.

The Person:

Potential candidates must be working within Regulatory Affairs with suitable experience working in the pharmaceutical/CRO industry. They will have prior experience within regulatory affairs whilst they will posess good interpersonal skills. Overall the successful Regualtory Associate will be able to work in Cambridge & have a suitable level of experience within a broad range of Regulatory Affairs projects.

Key Words:

Regulatory Affairs Associate, Pharmacovigilance, Drug Safety, Director, Manager, Management, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research, Cambridge, Job, Recruitment

For more information and to apply for this position, please contact Flame Pharma today on 0800 085 0858