The Senior Manager, Regulatory and PV Delivery is responsible for providing franchise liaison between Ergomed Plc and client on a multiple projects’ program and actively assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets. They also provide strategic regulatory guidance, training, coaching and mentoring to junior members; may be required to line manage members of staff.

Main 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 ensure satisfactory resolution of performance issues or delivery failures.
Provide franchise liaison between Ergomed Plc and client on a multiple projects’ program
Provide expert advice to Clients addressing complex queries and changes in local regulations/guidance.
Assist in securing recent business or repeated business by participating to BDMs,



developing and reviewing regulatory sections of proposals, regulatory costing and budgets.
Foster qualified working relationships with internal and external contacts at the local and international levels to ensure smooth and effective service delivery
Provide training, coaching and mentoring to junior members, may be required to line
manage 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.
Drive department / company initiatives, act as a change champion and successfully manage implementation of the changes (communication, timing and implementation plan)

Qualifications

Minimum 5 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.

Hands-on experience with post-marketing regulatory activities and lifecycle management highly recommended
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📌 Sr Manager Regulatory And Pv Network Melbourne
🏢 PrimeVigilance
📍 Melbourne