Principal Regulatory Consultant

Job Ref: J28415
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Permanent
Date Added: 11 September 2018
  • Huntingdon, Cambridgeshire, England, UK
  • Competitive
    ANNUM
  • Neal Panting
  • 01753 589601

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As the Principal Regulatory Consultant you will provide expert regulatory consultancy advice and services to internal and external clients, including regulatory strategy, preparation, review, submission and project management of regulatory applications as well as acting as the central point of contact for assigned.

Responsibilities

  • Providing expert regulatory consultancy advice and services to internal and external clients, including regulatory strategy, preparation, review, submission and project management of regulatory applications.
  • Acting as the central point of contact for assigned key clients and to be a source of scientific expertise.
  • Contribute to providing strategy and vision for developing the group and working closely with sales and marketing to promote services offered by the group.
  • Supporting a team of experts who are responsible for the delivery of Pharma Consulting services.
  • Maintaining an awareness of, and provide feedback on, client, industry and regulatory developments to input into the strategic development of the department and organisation as a whole.
  • Prepare, review, submit and project manage regulatory submissions in compliance with the applicable SOPs, regulatory guidelines and legislation.
  • Maintain high levels of customer service to meet client expectations at all times
  • Maintain electronic and hard copy project and regulatory files.
  • Participate in/present at internal and external training courses and conferences as required.
  • Provide input into monthly invoicing, and maintain financial control of assigned projects.
  • Mentor other members of the organisation as required.
  • Participate in management meetings (e.g., sales)
  • Support day to day management of the group. Develop and maintain effective working relationships with internal and external clients, regulatory authorities and suppliers.

Experience / Qualifications

  • PhD or BSc in Pharmaceutical Sciences or related relevant life sciences subject
  • Extensive experience from working in a pharmaceutical/healthcare product development environment
  • An in depth understanding of the drug development process and the role of regulatory affairs within that process
  • A sound technical and scientific understanding of one or more of manufacturing, non-clinical or clinical.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
11/10/2018 10:04:37
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