Regulatory Affairs Associate - Submissions

Recruiter
SRG Clinical
Location
Berkshire
Posted
01 Oct 2017
Closes
03 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
The Role:You will Support Regulatory processes and systems in the production and archiving of Regulatory Submissions supported by the Submission Operations team.Key Responsibilities: * Creation, formatting and filing of documents for electronic submissions to ensure that they are “submission ready”, working with Area and Affiliate regulatory personnel. * Perform pre-publishing tasks to ensure timely set up and maintenance supporting the publishing of regulatory submissions including Registration Management tasks, where applicable. * Expedite and coordinate a multitude of interrelated activities for a submission team, including Module 1 planners, in the development of published submissions within the required timelines. * Assist with co-ordination of publishing carried out by offsite contractors, including support for work allocation, resolution of queries and team review. * Perform post-publishing tasks including organization of submission printing where applicable, to ensure timely despatch and archival of regulatory submissions, and effective maintenance of supporting documentation. * Liaise and attend meetings with other company functions to meet submission timelines and plans. Skills/Experience Required:EducationLife Sciences Degree qualified.Knowledge * Experience of working in a regulatory submissions or registration management environment preferred * Documentum / XML experience preferred * Essential to work accurately and pay close attention to detail * Quick to learn new IT systems and processes and the ability to thrive in a changing environment and to re-prioritise workload to meet business needs If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.