Cpl Life Sciences – Regulatory

Regulatory Operations Associate

Location
Cambridge
Posted
23 Dec 2020
Closes
21 Jan 2021
Ref
JO-2012-459503
Contact
Sophie Malyon
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Regulatory Operations Associate

Cambridge Based - current remote working

Initial 12-month contract

Attractive salary and benefit package on offer.

Ideal opportunity for individuals who have recently graduated with a Life Sciences Degree or who have an interest in entry level Regulatory Operation opportunities.

CPL Life Sciences is collaborating with an internationally recognised biopharmaceutical company, who discover and develop innovative medicines globally. An opportunity has arisen within the Publishing & Document Processing team in which the team require a Regulatory Operations Associate to join their established team. This is a perfect opportunity for a recent Life Sciences University graduate or individuals seeking entry level opportunities into Regulatory Operations. Within this position you will assist in creating electronic navigation and publish submissions for regulatory agencies, validate/ QC submissions and submit documents to regulatory agencies.
Job Responsibilities include;
Responsible for end to end publishing of Regulatory submissions, including but not limited to:
Communicating with the Regulatory Affairs Submission Lead
Troubleshooting issues with systems or documents
Negotiating Timelines in the event of workload clashes
Working flexibly to ensure timely submission
Use in-house tools to aid submission (ISI Toolbox, Document Inventory)
Contribution towards process improvements

Required Qualifications, Skills and Experience
Must be eligible to live and work in the United Kingdom
Life Sciences degree or the equivalent
Basic understanding of medical/scientific terminology
Excellent level of written and verbal English
Good level of computer literacy with Microsoft applications
Very high level of accuracy and attention to detail
Excellent organization skills and ability to prioritize

If this position is of interest to yourself, please forward your up to date CV to Sophie on sophie.malyon@cpl.com

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