Regulatory Affairs Manager

Quotient Sciences has an exciting career opportunity for a Regulatory Affairs Manager to lead regulatory activities supporting phase 1 and 2 clinical trials of potential new medicines. The role comes with fantastic career development opportunities and a dynamic business culture.

Requirements

• Act as Regulatory Lead for cross-functional teams
• Responsible for planning, coordination and timely delivery of regulatory clinical trial submissions
• Prepare, review and QC key trial documents
• Prepare, collate, and submit clinical trial applications
• Act as point of contact for sponsors, MHRA, RECs, HRA, NHS Trusts and ARSAC
• Lead regulatory discussions in project meetings and advise project teams and sponsors on regulatory matters
• Liaise with MHRA, RECs, HRA, and ARSAC, and negotiate innovative and practical responses to their feedback
• Provide significant input into and/or management of continuous quality improvement initiatives and processes relating to regulatory activities
• Mentor colleagues and deliver training in regulatory processes
• Participate in sponsor audits and inspections by regulatory authorities
• Keep up-to-date and continue to extend knowledge of relevant laws and guidance
• Support business development activities

Benefits

• Fantastic career development opportunities
• Dynamic business culture