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

Learn more about our EEO & Accommodations request here.