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Regulatory Affairs Associate

  • Job reference: 929381
  • Location: Cambridge, Cambridgeshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 10/01/2020

Orion Group Sciences are looking for a Regulatory Affairs Associate for our multinational pharmaceutical client based in the Cambridgeshire area on an initial 12-month contract with the potential to extend.

Job Purpose

The Regulatory Affairs Associate under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents for one or more assigned projects. Working with Oncology Team.

Main Responsibilities of the role

  • Assist Regional Regulatory Lead to support regional regulatory filing activities (e.g. core CTA/IMPD development and submission)
  • Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
  • Coordinate collection of functional documents in support of regulatory applications
  • Prepare regulatory packages and cross-reference letters to support investigator sponsored studies
  • Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies
  • Create and maintain product regulatory history documents through company systems and appropriately archive all regulatory documents and agency communications
  • As appropriate may participate in GRT to support execution of regulatory strategy
  • Respond to specific requests from and communicate relevant issues to GRT
  • Support the development and execution of GRT goals
  • Review regional component of the Global Regulatory Plan and provide input to operational deliverables
  • May support RRL in review of promotional materials for commercial activities
  • Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
  • Support process improvement initiatives, standards development, and metrics

Desired Experience and Background of the successful candidate

  • Strong communication skills - oral and written
  • Organizational skills
  • Understanding of drug development process

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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