CK Group
,
Slough, Berkshire
Global Regulatory Lead
Overview
CK Clinical are recruiting for a Global Regulatory Lead to join a pharmaceutical company at their site based in Slough on a contract basis. This contract is Outside IR35. The Role: The main purpose of the role will be to: - Drive global regulatory strategy and oversight of implementation/execution in alignment. - Act as primary contact point for any regulatory questions related to the assigned projects and/or assets, and support any key interactions with health authorities. - Be accountable for the timely development and implementation of the global regulatory strategy and plan(s). Further responsibilities will include: - Accountability for the review of global/regional submission key documents and ensuring global alignment. - Participating and contributing to global strategic initiatives and tactical plans related to the gathering and analyses of customer insights. - Assisting in regulatory initiatives leading to process improvement and development. Your Background: To succeed in this role, you will come from a Life Science background and have work experience in Regulatory Affairs. Knowledge of global regulatory procedures & legislation for overall drug development, regional regulatory experience, clinical trial submission, product registration, line extension & license maintenance. Global regulatory experience is a plus. For more information or to apply for this Global Regulatory Lead position, please contact CK Group, quoting job ref 48015. It is essential that applicants hold entitlement to work in the UK.