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Regulatory Affairs Operations Associate 29862

  • Job reference: 931385
  • Location: Uxbridge, London
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 15/07/2020

Orion Group Life Sciences are looking for a Regulatory Affairs Operations Associate (GRAAS) for our Multinational Pharmaceutical client based in the Middlesex area on an initial 12-month contract with the potential to extend.


Job Purpose

  • Support the tracking and archiving of regulatory dossiers
  • Maintain regulatory document management systems and tracking systems
  • Maintain core dossier components
  • Quality control of archive and tracking systems
  • Primary Regulatory Operations point of contact between TAs/CMC and publishing teams



Main Responsibilities of the role

  • Maintenance of regulatory tracking systems: Data entry, administration and
    reporting from regulatory registration tracking system; maintenance of product
    history logs;
  • System administration: administration of document management systems; maintenance of team Sharepoint sites and associated documentation;
  • Regulatory archive: submission archival of regulatory dossiers, agency correspondence and records of contact to regulatory archive; upload to document management system;
    maintenance of product history documents; regulatory information data entry and document linking;
  • Quality control: regulatory information data entries and links; regulatory archive locations and file naming Information requests: fill internal requests for information and documentation
  • Metrics generation: liaison with internal customers to determine key performance and compliance indicators; liaise with reporting groups for data system outputs
  • External partners and vendors: external partner document exchange, support
    Training: contribute to the development and roll out of training documentation


    Desired Experience and Background of the successful candidate
  • Working in teams
  • Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations and Regulatory Guidance
  • Use of document management systems and databases
  • Good written and verbal communication skills
  • General understanding of industry practice and standards
  • Attention to detail
  • Relationship building
  • Time and project management skills
  • Organisational skills

    #pharmaceutical #pharma #multinational #product

For more information on this role, call Ian Towler on +44 (0) 2039944701 or email Ian.towler@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 931385


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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