▷ Only 24h Left : Regulatory Operations Specialist III

Job Overview :

Responsible for creation / revision / compilation / approval of Specifications / Documents for submission by Fortrea clients to US, EU, Japan, and ROW health authorities and oversight of the same, as applicable.

Summary of Responsibilities :

• These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally :
• Facilitate and support preparation, compilation and review of product quality (CMC) and other regulatory documents to support product development or submissions to various countries across the world for product registrations or post approval life cycle maintenance, as applicable.
• Facilitate coordination and interaction with cross functional teams / departments for evaluation / impact assessment of change control, review implementation strategy and required documentation governing the change and manage OOS, OOT or other product related changes, as applicable.
• Manage day-to-day operations and delivery for specific regulatory affairs engagements; oversee assigned project, including all aspects of regulatory submissions.
• Coordinate and interact with various departments like Procurement, Analytical, Technical Assurance and External manufacturers / sites, Suppliers and Distributors to understand the change, impact assessment, implementation strategy and required documentation governing the change, as applicable.
• Facilitate coordination and support for financial data management, Business plan file creation and maintenance, Supplier data management and PO creation as required.
• Facilitate coordination to create and update global labeling documents and its content and format to meet health authority requirements and client internal standards, as applicable.
• Lead stability data evaluation and report preparation, dissolution profile evaluation etc. as applicable.
• Escalate the potential issues and serve as analytical strategist and coordinator in crisis management situation, as applicable.
• Co-ordinate Data Management activities, review and submission of Import / Export Licenses, Dual Use NOC's and Import, as applicable.
• Work closely with clients to ensure client satisfaction, in transition and delivery and ensure delivery of services meets or exceeds Service Level Agreement.
• Generation of monthly status, staff member performance and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
• Resolve project-related problems within their area of expertise.
• Work closely with QA department at Fortrea to develop SOPs and training material and provide training as appropriate.
• Co-ordinate import, export licenses and qualification of analytical instruments, Change Control Management, as applicable.
• Update and review packaging specific documents and evaluate the trigger of change on packaging documents as received from the stakeholders, as applicable.
• Manage supplier agreement process for new packaging development projects and commercial specification updates, optimize existing packaging components under the supervision of Packaging Development Engineer and / or reporting manager, as applicable.
• Assist in Global Triage meetings as required.
• Seek guidance from other team members and manager as needed and keep up to date knowledge of various regulatory guidelines required for pharmaceutical product registration and product life cycle maintenance.
• Implement use of consistent, efficient, and quality processes to meet timelines and deliverables according to client requirements.
• Update and maintain internal and external (client) trackers for metrics, perform and document quality checks, as applicable.
• Assist in onboarding, training and mentoring junior staff and perform additional duties as assigned by the manager.
• Maintain training related documentation as per Fortrea and client requirements.

Qualifications (Minimum Required) :

Experience (Minimum Required) :

Preferred Qualifications Include :

Physical Demands / Work Environment :

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