Job Description
Job Title: Regulatory Contractor
Location: Maidenhead
Contract: 12 Months
Hours: 37.5 hours per week
Rates: £25-30 p/h
Job Description
SRG are looking for a regulatory contractor to join a global pharmaceutical company based in Maidenhead. The Regulatory Contractor is responsible for providing global regulatory expertise for Clinical Trials. They are the primary interface between global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes.
Duties and Responsibilities
1. Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc.
2. Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
3. Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols.
4. Ensure approved company CTA processes are followed within agreed timelines.
5. Good understanding of CTR process and requirements.
6. Monitor key project milestones (ac...