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About the Role
The Manager, Regulatory and PV Delivery is responsible for developing strategy based on regulatory requirements and driving regulatory and PV deliverables according to an established plan. This role actively assists senior management in securing new business by participating in Business Development Meetings (BDMs) and contributing to proposals and budgets. The position also provides strategic regulatory guidance, training, coaching, and mentoring to junior team members, with potential line management responsibilities.
Responsibilities
- Assume leadership and functional representation for projects and/or deliverables of high complexity, ensuring effective and rapid coordination, management, and execution of regulatory tasks.
- Drive the team to meet agreed targets and comply with 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 ensure 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 escalate any Out of Scope (OoS) issues.
- Assist in securing new business or repeated business by participating in BDMs, developing and reviewing regulatory sections of proposals, and 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.
- Provide responses to any audit/inspection findings or follow-up questions.
- Prepare and/or contribute to the Regulatory Newsletter and update the 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 the implementation of changes (communication, timing, and implementation plan).
Requirements
- Minimum 3 years within the pharmaceutical or CRO industry or a Regulatory body.
- 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.
Location
- Remote
Work Type
- Full-time
Experience Level
- Manager
- 3+ years
- 3+ years in a leading/project management role
About the Company
- PrimeVigilance is a global pharmacovigilance specialist whose teams help clients navigate complex regulations while keeping patient safety at the center of every decision.
- The company's culture is built on kindness, flexibility, growth, and belonging, where colleagues support one another and good ideas are heard.
- Ergomed Group's values include Quality, Integrity and trust, Drive and passion, Agility and responsiveness, Belonging, and Collaborative partnerships.