Regulatory Affairs Operations Expert

6 hours ago

London, Greater London, United Kingdom PE Global Full time
About the Role

The Regulatory Affairs Operations team at PE Global is looking for a highly skilled Regulatory Records Management Expert to join their team. This is a contract role with a leading multinational Pharma client based in London, offering a unique chance to work on a high-profile project.

The successful candidate will be responsible for supporting the implementation of Regulatory Records Management related to the client's product portfolios and Mergers, Acquisitions and Divestment (MA&D) activities. This involves supporting assigned tasks related to archiving, retention, and timely disposition of impacted Regulatory Records under the supervision of the Head, RA Ops Mergers and Acquisitions.

Key Responsibilities:

  • Support 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.
  • Responsible for receiving, classifying, scanning, indexing, and archival of regulatory relevant records in support of MA&D activities.
  • Ensure timely generation of reports; assist Operational team in developing and maintaining meaningful KPI's/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); assist in legal hold implementation as per Legal Department needs.
  • Collaborate with RA Operational team in development, implementation, communication, training, and enforcement of Regulatory Records Management best practices.
  • Proactively identify opportunities for operational process or system related improvements relevant to both paper and electronic records management.

Requirements:

  • 3+ years' experience in Pharma (preferably in the area of Regulatory Records Management).
  • Familiar with drug development process, 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.
  • Project management and time management skills to manage multiple ongoing projects simultaneously.
  • Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly.
  • Works independently and with minimal supervision.
  • Good analytical and problem-solving skills.
  • Ability to coordinate and work effectively with cross-functional teams.

This role offers a competitive salary of £60,000 - £70,000 per annum, commensurate with experience. Interested candidates should submit an updated CV.

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