Regulatory Records Specialist

2 weeks ago


London, Greater London, United Kingdom Russell Tobin Full time
Job Overview
As a Regulatory Records Associate at Russell Tobin, you will play a vital role in supporting the implementation of Regulatory Records Management. This individual contributor position is responsible for categorizing and classifying information related to company product portfolios and Mergers, Acquisitions, and Divestment activities.

Key Responsibilities
• Support assigned tasks related to archiving, retention, and timely disposition of impacted Regulatory Records under the supervision of Head, RA Ops Mergers and Acquisitions.
• Receive, track, and respond to inquiries and requests for retrieval of stored RA records in a timely manner.
• Classify, scan, index, and archive regulatory relevant records in support of MA&D activities.
• Generate reports and assist Operational team in developing and maintaining meaningful KPIs/metrics related to physical and electronic record transfers.
• Participate in the development and review of line function-related records management processes and procedures.
• Provide audit support related to RA records managed by RA Operations, including support for MA&D related needs.
• Support litigation teams on document discovery requests (due diligence) and assist in legal hold implementation as per Legal Department needs.
• Collaborate with RA Operational team in the development, implementation, communication, training, and enforcement of Regulatory Records Management best practices.

Requirements
• 3+ years of experience in Pharma, preferably in Regulatory Records Management
• Familiarity with drug development process, worldwide regulatory practices, electronic submission guidelines, and requirements
• Hands-on experience with regulatory records or document management systems and related software/tools
• Working knowledge of regulatory affairs
• Proficiency with computer programs/systems (MS Office, etc.) with demonstrated ability to learn new systems quickly
• Ability to work independently and with minimal supervision
• Good analytical and problem-solving skills
• Ability to coordinate and work effectively with cross-functional teams

Estimated Salary: £28.48/hour PAYE

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