Regulatory Affairs Specialist

Regulatory Professionals
United Kingdom
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Regulatory Affairs Specialist Competitive salary Location: Uxbridge Reference: J30181 An opportunity has arisen for a Regulatory Affairs Specialist join a global Biopharmaceutical company who work to provide innovative treatments to patients worldwide. The ideal candidate with have knowledge of IND, NDA, MAA and CTD requirements and guidelines and experience working in Electronic Document Management Systems (EDMS). Responsibilities will include: * Supporting 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 * Planning, gathering, tracking, dispatching and archiving regulatory documents and submissions in paper, eCTD and other electronic format * Creating, assembling and publishing both major and routine global paper and electronic submissions (for example DSURs, PIPs, Annual Reports, Periodic Safety Reports, Supplements and Amendments) * Working with regulatory document authors to achieve resolution and ensure documents comply with regulatory and company guidance and template specification * Maintaining all regulatory and FDA correspondences and archiving into EDMS within timeframes Essentials: * Bachelor's Degree (or equivalent experience) * Regulatory Operations and Pharmaceutical industry experience * Experience publishing eCTD using electronic publishing system and tools * Knowledge of industry tends with electronic submissions * Experience with MS Office Suite and Adobe Acrobat application Regulatory Operations, IND, NDA, MAA, eCTD, Pharmaceutical, lifecycle management, electronic publishing, Uxbridge, West London