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Regulatory Affairs Manager

  • Job reference: 924004
  • Location: Uxbridge, Middlesex
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 19/02/2019

Orion group are recruiting a Regulatory Affairs Manager on behalf of our Multinational Biotechnology Client based in Uxbridge, UK - 12-month contract

The Regulatory Professional under the direction of a Regional Regulatory Lead will lead compilation of CMC regulatory packages for submission and may be the lead for a program under supervision.

Collect and/or create country-specific documents for regulatory filings worldwide.

Compile and maintain CTA/MA documentation (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead.

Ensure compliance via timely submissions to regulatory agencies.

Coordinate the collection of functional documents in support of regulatory applications.

Interface with Regulatory Operations

As appropriate support execution of regulatory strategy.

Support process improvement initiatives, standards development, and metrics. Assist in template development and maintenance.

Contribute to the training and supervision of junior staff.

Key Skills: Strong communication skills - oral and written; Ability to multi-task in a fast paced environment; Organizational skills; Understanding of drug development process; knowledge and understanding of CMC requirements, especially country-specific documents for international filings; Familiarity with Document Management Systems.


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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