Description
An excellent opportunity has arisen for a Senior Regulatory Information Officer to join a Top 15 global pharmaceutical company on a permanent basis based on the Hertfordshire / Essex border. This role has become available due to an increase in company growth.
Skills & Experience
You will hold a Bachelor's Degree in Life Sciences or Information Technology (or equivalent). As an ideal candidate you should have extensive experience in Pharmaceutical Regulatory Affairs, particularly in regulatory submissions process (publishing). Knowledge in global regulatory requirements, industry regulatory standards will be required for this role. A solid understanding of the drug development process, generics and branded product development would be a plus.
Main Responsibilities
" Act as the main contact between the business units, information technology and support teams
" Provide business project management to support the delivery of IT systems / upgrades and new implementation projects with focus on regulatory data management and submission publishing. Includes the provision of business consulting support for regulatory functions as appropriate for shared and global solutions.
" Work across regions and functions with staff at all levels to ensure regulatory systems are developed and enhanced to meet the diverse regulatory business needs
" Leverage deep business or technology expertise to partner with the above functions; understand evolving regulatory guidance; understand new user requirements and translate those into project proposals for change
" Analyse and challenge stated requirements in a professional manner when required to derive actual, clear, or hidden requirements
" Provide business support for production systems in scope
" Maintain current knowledge of existing and emerging health authority regulations and programs.
" International and domestic travel will be required, variable based on business need 10-20%
For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk
