PE Global

Regulatory Compliance Specialist

About the Employer

Job Description

PE Global are currently recruiting for a Regulatory Records Associate for a contract role with a leading multinational Pharma client based in London - Hybrid. An individual contributor position in Regulatory Affairs Operations responsible for supporting the implementation of Regulatory Records Management (categorizing and classifying information) related to the client’s product portfolios and Mergers, Acquisitions and Divestment (MA&D) activities. Job Responsibilities • Under the supervision of Head, RA Ops Mergers and Acquisitions, support assigned tasks related to the areas of archiving, retention, and timely disposition of impacted Regulatory Records. • Receives, tracks, and responds 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, as per guidance from RA Ops M&A team, the litigation team on document discovery requests (due diligence); assist in legal hold implementation as per Legal Department needs • Collaborates 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. Interested candidates should submit an updated CV. Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK