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Senior Regulatory Submissions Coordinator

Senior Regulatory Submissions Coordinator

Posted 24 May by Park Street People
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Our client, a global pharmaceutical company, is currently looking for a Senior Regulatory Submissions Coordinator to join their team in Cambridge. This role can be offered on a 12-month or 24-month contract.

This is a great opportunity to work with a team who take provide in working to the highest standards, passionate about delivering excellence and focused on sharing regulatory best practice and guidance throughout the wider business.

Key Responsibilities

  • Manage the regulatory submissions for clinical trials, paediatrics and marketing applications such as INDs, eCTDs and NDAs
  • Oversee the regulatory submissions management and tracking systems by ensuring its correct administration and data entry
  • Ensure all regulatory information is accurately located and named
  • Adhere to regulatory publishing policies and procedures

Requirements

  • Previous Regulatory Affairs experience within the pharmaceutical industry
  • Strong understanding of Regulatory submissions
  • Great knowledge of Clinical Trial Applications and Marketing Authorisations is advantageous
  • Exposure of Regulatory Affairs legislation and procedures
  • Excellent knowledge of document management systems
  • Excellent communication and time management skills

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.

Reference: 42812080

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