Reference Number: JO-2209-501878
Principal Regulatory Consultant
Job Type: Permanent
Job Title: Principal Regulatory Consultant
Job Number: JO-2209-501878
Reporting to: Team Leader / Director
The Principal Regulatory Consultant will be responsible for managing a portfolio of projects for a number of clients. This will encompass projects in clinical development, at MAA filing stage and post approval lifecycle management Globally.
• Take responsibility for Company activities e.g. teambuilding sessions, as requested.
• Support regulatory projects on behalf of the client including supervised liaison and negotiation with regulatory authorities.
• Lead regulatory projects on behalf of the client including direct liaison and negotiation with regulatory authorities.
• Support and Manage regulatory procedures at both the national and EU level. Support US projects.
• Manage US projects
• Prepare regulatory submissions including clinical trial applications and amendments, MAA dossiers and variations. Assist with preparation of scientific advice requests and PIPs and Orphan drug applications
• Oversee preparation of regulatory submissions including clinical trial applications and amendments, scientific advice requests, PIPs, Orphan drug applications, MAA dossiers and variations.
• Provide regulatory strategic advice on guidelines, legislation and procedures to clients on assigned projects
• Analyse changes in the regulatory environment and legislation for impact on project/plans and the overall business.
• Prepare regulatory submissions and agency interactions.
• Manage regulatory submissions and interactions.
• Give input to regulatory plans to meet project and client goals.
• Develop regulatory plans to meet project and client goals
• Prepare and execute business and financial plans
Salary: Up to £150,000 per annum with generous perks/bonus/benefits
Looking to speak to experienced professionals looking for a new challenge in 2023. For more information contact George Eyre at firstname.lastname@example.org to schedule a call to discuss in more depth. If you know of anyone with this type of experience we do offer a strong referral bonus per successful applicant.