Regulatory Operations Principal Specialist

Job Overview

• Perform various project management and regulatory affairs activities for Fortrea clients.
• Manage team including performance reviews, human resource issues, and assist Senior Management in assigning resources to projects as required.
• Manage, coordinate and oversee the overall Regulatory Operations associated with creation/revision/compilation/approval of specifications, regulatory and labeling documents across the product lifecycle for submission by Fortrea clients to US, EU, Japan, and ROW health authorities within the agreed/stated timelines, as applicable.
• The post holder is responsible for supporting team members in providing this service to clients either as a support function to the client project groups or as stand-alone business.
• Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
  

Summary Of Responsibilities

• Provide governance and management on tail spend solution
• Accountable for the tail spend provider performance and providing necessary oversight to our provider of sourcing services – savings delivery, KPI, SLAs, etc.
• Cost reduction target : 7% reduction YoY vs std cost
• Payment terms negotiation: ideally bringing payment terms to target of 90 days
• Manage and mitigate risks associated with the tail spend provider relationship while strategically driving the vendor’s performance and identifying cost savings opportunities
• Oversee the transition of services to tail spend solution partner and ongoing relationship management
• Build and maintain excellent relationships with internal clients and colleagues at all levels.
• Point of escalation and business / provider liaison for issues
• Collaborate closely with the Category Strategy Leads, Site/Regional Procurement and Purchase-Pay-Pay Shared Services colleagues to enable an end-to-end procurement process
  

Required Experience

• Bachelor’s Degree
• >4 years of experience in indirect sourcing, procurement, or category management
• Highly proficient in analytics, negotiations, program management and communications