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Regulatory Affairs Manager, RIM

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
Regulatory Affairs Jobs
Country:
United Kingdom
Region:
Oxfordshire
Contract Type:
Permanent
Currency:
£
Salary:
50,000 to 68,000 per annum
Salary Description:
car allowance and bonus
Posted:
11-Jun-19
Recruiter:
Key People
Job Ref:
BBBH24227

An excellent opportunity has arisen for an experienced Regulatory Information Manager (RIM) to join a leading Biopharma client based in the Oxfordshire area. The ideal person will have strong regulatory and VEEVA Vault background, as well as line management.

Responsibilities:

*Act as ambassador for Vault RIM across R&D
*Manage communication regarding company Vault RIM, including newsletters and maintaining and updating the intranet page for the system
*Create and maintain excellent relationships across GRA, R&D contributing groups, and IT, ensuring information management needs are met and requests for information are handled in a timely fashion;
*Serve as the Regulatory point of contact for R&D Records and Information Management activities and strategies
*Interfaces with system end-users to identify necessary ad hoc regulatory/compliance related system updates and resolves requests relevant to in-scope activities;
*Work closely with IT and vendor (Veeva) to support Veeva Vault RIM system updates and releases;
*In conjunction with IT, manage user accounts in the company Vault RIM including user permissions and security profiles;
*Manage Veeva Vault RIM configuration requests by working with IT, Veeva and functional GRA representatives;
*Support IT in validation testing as needed;
*Develops SOPs, Manuals, or other training materials for Veeva Vault RIM and works collaboratively with QA and Regulatory Affairs teams.

Experience Required:

*Bachelor's degree
*Maintain Veeva Administrator's Certificate
*Excellent communicator and team player who gets the job done - this is a hands-on position
*Minimum 3 years of Regulatory Affairs experienced required
*Strong understanding of Regulatory activities, projects, and processes
*Experience in Veeva Vault Regulatory Information Management software
*A working knowledge of Pharmaceutical/Biotech Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA, etc.)
*Ability to multitask effectively in a fast-paced environment with often shifting priorities
*Ability to work independently with minimal supervision or direction
*Excellent verbal and written communication skills
*Experience with extensive document archiving is required
*Experience managing vendors, contractors, and direct reports

For further details about this role, please contact Tim Barratt on or email a copy of your CV to tbarratt@keypeople.co.uk


Closing Date:
10/07/2019

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