Regulatory Records Management Specialist

1 week ago

London, Greater London, United Kingdom Russell Tobin Full time
Job Overview

Russell Tobin is seeking a Regulatory Records Associate for a 06-month contract in London. The successful candidate will work hybridly, supporting the implementation of Regulatory Records Management.

The hourly wage for this position is £28.48/hour.

Key Responsibilities
  • Support the Head of RA Ops Mergers and Acquisitions in assigned tasks related to archiving, retention, and timely disposition of impacted Regulatory Records.
  • 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 in a timely manner and assist the Operational team in developing 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 the litigation team on document discovery requests (due diligence) and assist in legal hold implementation as per Legal Department needs.
  • Collaborate with the RA Operational team in developing, implementing, communicating, training, and enforcing Regulatory Records Management best practices.
Requirements
  • BS or MS degree with 3+ years of Regulatory and/or Archives/Records management experience within the Pharmaceutical industry.
  • Mastery of English as a business language, additional language an asset.
  • 3+ years' experience in Pharma (preferably in Regulatory Records Management), familiarity with drug development processes, worldwide regulatory practices, electronic submission guidelines, and requirements, as well as records/document management processes.
  • Hands-on experience with regulatory records or document management systems and related software/tools preferred.
  • Working knowledge of regulatory affairs, project management, time management skills to manage multiple ongoing projects simultaneously, proficiency with computer programs/systems (MS office, etc.), ability to learn new systems quickly.
About the Opportunity

This role offers a unique chance to work with a leading company in the pharmaceutical industry. As a Regulatory Records Associate, you will have the opportunity to develop your skills and expertise in Regulatory Records Management.

The estimated salary for this position is £28.48/hour.

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