Overview

Reference Number: JO-2209-501878
Principal Regulatory Consultant
Rate: Negotiable
Job Type: Permanent
Location: Hertford

Job Title: Principal Regulatory Consultant

Job Number: JO-2209-501878

Reporting to: Team Leader / Director

Description:

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.

Key Responsibilities:

• 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 george.eyre@cpl.com 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.