Compliance and Records Specialist

2 weeks ago


London, Greater London, United Kingdom PE Global Full time

We are seeking a highly skilled Regulatory Compliance Specialist to join our client's team in London. As a key member of the Regulatory Affairs Operations team, you will play a critical role in supporting the implementation of regulatory records management processes related to product portfolios and mergers, acquisitions, and divestments (MA&D) activities.

This exciting opportunity offers the chance to work with a leading multinational pharmaceutical client and contribute to the success of their regulatory affairs operations. With 3+ years' experience in the pharmaceutical industry, preferably in regulatory records management, you will be responsible for archiving, retention, and timely disposition of impacted regulatory records, receiving and responding to inquiries, and collaborating with cross-functional teams.

Key Responsibilities:

  • Support assigned tasks related to archiving, retention, and disposition of regulatory records
  • Receive, track, and respond to inquiries and requests for retrieval of stored records
  • Collaborate with RA Operations team to develop and maintain 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

Requirements:

  • 3+ years' experience in the pharmaceutical industry, 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

The estimated salary for this position is £45,000 - £55,000 per annum, depending on experience. If you are a detail-oriented and organized individual with excellent communication skills, please submit your updated CV for consideration.

***Please note that our client cannot assist with any visa sponsorship, and candidates must have the correct visa to live and work in the UK.***



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