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
  

Qualifications (Minimum Required)

• Bachelor’s in pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or Masters) with experience of 7-9 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR
• Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream with at least 7-9 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 7-9 years of experience will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
• Speaking-English and/or other languages as applicable
  

Experience (Minimum Required)

• At least 1+ year experience in project management and people management is desirable
• Industry experience of which 7-9 years of experience in the job discipline (e.g. Regulatory Affairs / Quality Assurance / Analytical science / Packaging, polymer and/or printing stream / Formulation science / Material Management and overall Drug Development and Manufacturing Process.
• Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.
• Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable
• Good organizational and time management ability.
• Good analytical capabilities and Customer focus.
• Good verbal, written and presentation skills.
• Leadership capabilities.
• High degree of accuracy with attention to detail.
• Ensure client and global regulatory compliance.
• Anticipate/identify problems and takes appropriate action to correct.
• Capabilities to face internal and external Audit situation.
  

Preferred Qualifications Include

• Bachelor’s in pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or Masters) with experience of 7-9 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR
• Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream with at least 7-9 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 7-9 years of experience will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
• Knowledge of data management system, pharmaceutical product life cycle and Management Information System (MIS) will be preferred.
• Knowledge of data management system and pharmaceutical product life cycle will be preferred.
• 1+ year experience in project management and people management is desirable.
• Diploma or certification in Regulatory Affairs will be preferred.
  

Work Environment

• Work environment: Office environment