Senior Manager, Regulatory and PV Delivery

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 new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets. 
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery 
• Provide training, coaching and mentoring to junior members of staff, 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)

• 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

Why PrimeVigilance

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

We offer: 

• Training and career development opportunities internally  
• Strong emphasis on personal and professional growth 
• Friendly, supportive working environment 
• Opportunity to work with colleagues based all over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!  

• Quality 
• Integrity & Trust  
• Drive & Passion  
• Agility & Responsiveness  
• Belonging 
• Collaborative Partnerships  

We look forward to welcoming your application. 
#LI remote