Regulatory Affairs Submission Specialist

Recruiter
Regulatory Professionals
Location
London (Greater)
Posted
29 Sep 2017
Closes
03 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
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.