Job Description
Job Title: Regulatory Affairs Submission Associate
Location: Maidenhead
Contract: 12 months
Hours: 37.5 hours
Rates: £20-22p/h
Job Description
SRG are looking for a regulatory affairs submission associate for a pharmaceutical company based in maidenhead. You will be responsible for establishing and maintaining submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfils Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications.
Duties and Responsibilities
1. Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
2. Acts as Submission Management support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables.
3. Participates in submiss...