Strategic Regulatory & PV Delivery Lead

Primevigilance; Greater London; On-site; GBP 90,000 - 130,000; Full time

Job summary

PrimeVigilance in London, England, United Kingdom seeks a Manager, Regulatory and PV Delivery to lead complex regulatory and PV initiatives. You will develop strategy based on requirements, drive timely deliverables, and mentor junior staff while supporting proposals and budgets.

You will provide expert regulatory guidance to clients, manage budgets, and participate in audits, inspections, and change initiatives. The role is based in London with a collaborative, high-performing team.

Qualifications

• Minimum 3 years within pharmaceutical or CRO industry or Regulatory body, with at least 3 years in a leading/project management role.
• Proven ability to successfully manage global projects.
• Expert knowledge of ICH GCP and/or GVP and relevant legislation for territories of competency.

Responsibilities

• Lead projects and deliver regulatory tasks for high complexity, driving timely completion within plans and budgets.
• Provide strategic input to clients and address regulatory risks with preventive actions.
• Advise clients on changes in local regulations and guidance to ensure compliant deliverables.
• Monitor budgets, hours vs. budget, and escalate OoS for departmental deliverables.
• Contribute to business development by participating in BDMs and developing regulatory sections of proposals.
• Prepare client invoices and review vendor invoices; mentor junior staff and support audits/inspections.

Skills

Leadership

Project management

Regulatory affairs

Pharmacovigilance

GxP

Education

Bachelor's in life sciences

Tools

Regulatory databases

GxP systems

Job description

PrimeVigilance in London, England, United Kingdom seeks a Manager, Regulatory and PV Delivery to lead complex regulatory and PV initiatives. You will develop strategy based on requirements, drive timely deliverables, and mentor junior staff while supporting proposals and budgets.

You will provide expert regulatory guidance to clients, manage budgets, and participate in audits, inspections, and change initiatives. The role is based in London with a collaborative, high-performing team.