Director of Regulatory Affairs Urgently Required

RBW Consulting
60,000 - 80,000
07 Oct 2017
07 Nov 2017
Contract Type
Full Time
One of the countries leading pharmaceutical companies, with an innovative mind-set and a fantastic approach to ethical business, have recently approached me regarding a very important and critical role within their business. My client is looking for a RA Director to join their team on a full time basis to be located full time at their Dartford site where they will be required to: Add structure to the regulatory department to ensure all the projects meet client expectations Ensure compliance with the appropriate guidelines and regulations Head up Regulatory Intelligence research activities for the internal company database Provide strategic and regulatory support to clients Prepare technical assessments Review marketing and clinical trial submission documentation for accuracy and compliance to internal and external regulations Manage submissions and prepare submission dossier as required by clients Identify gaps in regulatory that you can then improve Liaise with regulatory and government bodies Act as client lead for regulatory Perform vendor management activities Other duties and responsibilities as assigned The correct candidate for this opportunity is: 10 Years pharma or CRO experience Bachelors in Biology, Chemistry or related field Working experience of a large range of regulatory submission types including regulatory document writing experience Experience of clinical trial submission requirements and regulations Biologics experience in product development Previous CMC regulatory experience Experience with GXP and ICH practices If this sounds like your kind of role, then reach out now as it won’t be around for long!