Global PV Regulatory Delivery Manager

Ergomed Group; Greater London; Hybrid; GBP 65,000 - 95,000; Full time

Job summary

PrimeVigilance, part of Ergomed Group, is seeking a Manager, Regulatory and PV Delivery to shape strategy and drive regulatory and PV deliverables. You will mentor junior staff and help secure new business through bids and proposals.

Based in the UK, you will lead cross-functional teams on high-complexity projects, ensure regulatory compliance, and provide counsel on local requirements across territories. This role offers a chance to impact patient safety on a global scale.

Qualifications

• Minimum 3 years within pharmaceutical or CRO industry or Regulatory body, of which 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 most relevant legislation/local requirements for territories of competency.

Responsibilities

• Assume leadership and functional representation for projects and/or deliverables of high complexity ensuring effective and rapid coordination and management and execution of regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
• Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and ensures satisfactory resolution of performance issues or delivery failures.
• Provide expert advice to Clients addressing complex queries and changes in local regulations/guidance.
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and elevate any OoS.
• Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets.
• Prepare client’s invoices and review/approve vendor’s project invoices
• Provide training, coaching and mentoring to junior members of staff
• Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow up questions.
• Prepare and/or contribute to the Regulatory Newsletter and update regulatory database when new information is available.
• Ensure collection, QC review and timely dissemination of all regulatory intelligence related to departmental deliverables. Support interpretation and impact analysis on legislation.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Drive department / company initiatives, act as a change champion and successfully manage implementation of the changes (communication, timing and implementation plan)

Skills

Regulatory leadership

Project management

Global projects

Job description

PrimeVigilance, part of Ergomed Group, is seeking a Manager, Regulatory and PV Delivery to shape strategy and drive regulatory and PV deliverables. You will mentor junior staff and help secure new business through bids and proposals.

Based in the UK, you will lead cross-functional teams on high-complexity projects, ensure regulatory compliance, and provide counsel on local requirements across territories. This role offers a chance to impact patient safety on a global scale.