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Regulatory Operations Associate

  • Job reference: 928108
  • Location: Uxbridge, London
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 09/10/2019

Orion Group are looking for a Regulatory Operations Associate for our multinational pharmaceutical client based in the Middlesex area on an initial 6-month contract with the potential to extend.

Job Purpose
Work as part of a global Regulatory Operations team, both leading and contributing to global filings.

Main Responsibilities of the role

  • Lead key submissions for EU, CAN, MENA and Emerging Markets
  • Compilation and publishing of submission dossiers for clinical trials, paediatrics and marketing applications
  • Work closely with submission content providers to advise on submission content, structure, planning and strategy
  • Work with publishing vendors
  • Regulatory submission source document review, formatting, & troubleshooting, including but not limited to, MS Office, Adobe Acrobat PDF, Acrobat Plug-ins and XML ensuring documents conform to style guide and internal/external regulations
  • Preparation of submission ready components from source documents according to regional regulatory agency guidance
  • Document management of ongoing submissions, e.g. building dossier structure, sourcing documents
  • Quality control of submission ready components and submission dossiers
  • Preparation, dispatch and tracking of electronic and paper media
  • Maintenance of submission information in Regulatory Registration Tracking system

Desired Experience and Background of the successful candidate

  • Bachelor's degree, or equivalent combination of education and experience
  • Specialist knowledge of pharmaceutical/biotech industry gained in operationally focused role
  • Demonstrated experience with Insight Publisher including associated publishing, validation, and review tools
  • Working with publishing vendors
  • Working in matrix environment
  • Working in Teams
  • Dossier and Submission related Regulatory Guidance for EU, MENA and the Emerging Markets
  • Successful submission and maintenance of marketing applications in multiple regions

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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