Job Description Principal Regulatory Consultant - Cambridgeshire

A leading Regulatory Consultancy in the Cambridge area have an exciting opportunity for a Principal Regulatory Consultant to join their International Regulatory Group as part of their continued expansion.

Title: Principal Regulatory Consultant

Location: Cambridgeshire, Hertfordshire

Specific Responsibilities:
• To provide regulatory consultancy services to internal and external clients, including preparation, review, submission and project management of regulatory applications. To act as the central point of contact for assigned key clients and to be a source of scientific expertise for the team.

• Maintain 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.

• Provide up to date regulatory advice to internal and external clients as required.

• 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. Develop and maintain effective working relationships with internal and external clients, regulatory authorities and suppliers.

• Participate in business development activities as required.

• Participate in/present at internal and external training courses and conferences as required.


Knowledge, Experience and Skills:

• 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 development of pharmaceutical/healthcare products


www.i-pharmconsulting.com


TO APPLY

If you would like to discuss this vacancy further, please call Joe Balfour on +44 (0)20 3189 2299, or email jbalfour@i-pharmconsulting.com. If this role is not suitable, Joe is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

Notes: PRINCIPAL / SENIOR REGULATORY CONSULTANT

GFA seeks a consultant with a good background (at least 5 years) in the development of pharmaceutical and biotechnology products and is already working in regulatory affairs. Candidates with a consultancy background in regulatory affairs would be preferred.