Principal Regulatory Consultant

Posted 13 September by Zest Business Group
Easy Apply

Are you a Senior Regulatory professional with an in depth understanding of the drug development process? Do you have exposure to Phase I and Phase II trials? Would you like to work in a consultancy environment working across a number of projects, helping shape the direction of the organisation? Please get in contact for a confidential discussion.

We are looking to identify a driven Principal Regulatory Consultant for a world leading drug development organisation in Cambridgeshire. Naturally, there is a competitive salary and benefits package attached to this role.

As 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 key clients.

Job 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.
  • Prepare, review, submit and project manage regulatory submissions in compliance with the applicable SOPs, regulatory guidelines and legislation.
  • Attend client project meetings (face to face and via teleconference) as required.
  • Provide input into monthly invoicing, and maintain financial control of assigned projects.
  • Mentor other members of the organisation as required.
  • Support day to day management of the group
  • Develop and maintain effective working relationships with internal and external clients, regulatory authorities and suppliers

Job Requirements:

  • PhD or BSc in Pharmaceutical Sciences or related relevant life sciences subject
  • Extensive experience from working in a pharmaceutical/healthcare product development environment
  • Phase I and Phase II experience is required
  • An in depth understanding of the drug development process and the role of regulatory affairs within that process

Reference: 36106123

Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.

Report this job