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Senior Associate Regulatory Affairs

  • Job reference: 922830
  • Location: Uxbridge, Middlesex
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 30/11/2018

The Orion Group are currently seeking Regulatory Affairs Senior Associates for their locations in Uxbridge and Cambridge.

The Regulatory Affairs Senior Associates will assist in the creation and submission of regulatory documents for one or more assigned projects.

Key responsibilities include:
* Assist Regional Regulatory Lead to support regional regulatory filing activities
* Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports)
* 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
* Respond to specific requests from and communicate relevant issues
* Review regional component of the Global Regulatory Plan and provide input to operational deliverables
* Provide regulatory support to Commercial, Medical and Clinical departments
* Support process improvement initiatives, standards development, and metrics

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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