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Regulatory Affairs Senior Manager

  • Job reference: 922839
  • 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 recruiting for a Senior Regulatory Affairs Manager, with specialism in the field of Oncology, for our multinational biotechnology client.

The role is concerned with acquiring and maintaining all the required licenses in order to support clinical trials and further development of investigational medicinal products; market commercially approved medicinal products as well as regulatory compliance.

Responsibilities:

  • Plans and manages regulatory submissions for products within portfolio in compliance with global filing plans and local regulatory requirements.
  • Implements product related regulatory strategies, Regulatory Affairs processes and activity planning.
  • Provides content guidance for regional regulatory documents and meetings in accordance with global strategy
  • Provides regulatory guidance on regional regulatory mechanisms to optimize product development
  • Supports regional label negotiation activities
  • participate in the development, and execution of regional regulatory product strategies
  • Communicates regulatory strategies within team
  • Develop predictions for expectations and risks associated with outcomes by regulatory agencies
  • Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance


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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