Regulatory Documents Coordinator
20 hours ago
We are seeking a highly skilled Regulatory Records Associate to join our team in London. The successful candidate will work on a 06-month contract, supporting the implementation of Regulatory Records Management.
The hourly wage for this position is £28.48/hour.
Duties and 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.
- 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.
Russell Tobin is a leading company in the pharmaceutical industry, dedicated to providing innovative solutions and services to our clients.
The estimated salary for this position is £28.48/hour.
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