Regulatory Affairs Submission Specialist

Regulatory Professionals
London (Greater)
29 Sep 2017
03 Nov 2017
Contract Type
Full Time
Regulatory Affairs Submission Specialist Competitive Salary Location: Uxbridge Reference: J30871 Regulatory Professionals are supporting the recruitment of a Regulatory Affairs Specialist who will have the opportunity to join a global Biopharmaceutical company, specialising in providing life changing treatments for those with unmet, urgent medical needs. They are looking for a talented and motivated individual to join their team, specialising in submissions. The responsibilities are outlined below: *Support of the Regulatory Affairs staff in the coordination, preparation and submission of all INDs, NDAs, MAAs and lifecycle management of these submissions using EDMS and electronic publishing. *Maintenance of all regulatory and FDA correspondences and archiving into EDMS. *Creating, assembling and publishing both major and routine global paper and electronic submissions. *Planning, gathering, tracking, dispatching and archiving regulatory documents and submissions in paper, eCTD and other electronic format. *Working with regulatory document authors to achieve resolution and ensure documents comply with regulatory, company guidance and template specification. The following qualifications and experience are necessary: *Achieved a Bachelor's Degree or equivalent. *Industry experience including Regulatory Operations. *Experience publishing eCTD using electronic publishing systems. *Knowledge of electronic submission trends. *Experience with MS Office Suite and Adobe Acrobat application. Our client also offers a brilliant salary, along with a strong benefits package. Regulatory Operations, IND, NDA, MAA, eCTD, Pharmaceutical, lifecycle management, electronic publishing, Uxbridge, West London, Hillingdon, Stratford, Ealing, Harrow, Hounslow, submissions, regulatory affairs.