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Regulatory Affairs Associate 29848

  • Job reference: 931360
  • Location: Uxbridge, London
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 13/07/2020

Orion Group Life Sciences have an exciting opportunity for a Regulatory Affairs Associate for our Multinational Pharmaceutical client based in the Middlesex area on an initial 12-month contract.


Job Purpose

The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents mostly related to clinical trials in the EU. Over time the scope could expand to also support other regulatory activities like post-approval variations, annual reports, pre-MAA filing or regulatory authority meeting preparations.

Main Responsibilities of the role

  • In collaboration with Regional Regulatory Lead create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications.
  • Ensure compliance via timely submissions to regulatory agencies.
  • Coordinate collection of functional documents in support of regulatory applications.
  • Coordinate QC of regulatory documentation (e.g. briefing packages).
  • Prepare regulatory packages and cross-reference letters to support investigator initiated studies. Complete regulatory forms to support agency communications (e.g. EudraCT).
  • Support process improvement initiatives, standards development, and metrics.
  • Assist in template development and maintenance.
  • Actively support regulatory compliance.

Desired Experience and Background of the successful candidate

  • Good communication skills - oral and written.
  • Organizational skills. Understanding of drug development process.
  • Previous experience in pharmaceutical industry of at least 1 year is preferred, ideally in a regulatory affairs department.

#pharmaceutical #medical #multinational #product #drug #regulatoryaffairs #CTA #MA

For more information on this role, call Kate O' Sullivan on +44 (0) 2039 944702 or email Kate.OSullivan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 931360


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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