Regulatory Affairs Manager, RIM

Key People

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Job ID :

15113


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc,Master of Science,phD


Address 1 :

United Kingdom,Oxfordshire,Oxfordshire,


Key Skills :

RIM, regulatory, information, management, publishing, regs


Salary :

£50000 - £68000 per annum + car allowance and bonus


Date Posted :

17 Jul, 2019



Company Name :

Key People


Location1 :

Oxfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

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



Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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