Regulatory Compliance Coordinator
1 day ago
The Regulatory Records Associate role at Russell Tobin involves supporting the implementation of Regulatory Records Management. You will work closely with the RA Ops Mergers and Acquisitions team to ensure compliance with regulatory requirements and company policies.
Key Responsibilities
• Support the RA Ops Mergers and Acquisitions team in categorizing and classifying information related to company product portfolios and Mergers, Acquisitions, and Divestment activities.
• 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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