Overview

Reference Number: JO-1908-435394
Associate Director Regulatory Affairs
Rate: Negotiable
Job Type: Permanent
Location: Cambridge

Associate Director, Regulatory Affairs
Cambridge
Permanent

Are you inspired by developing your career in a stimulating environment where you can make a profound difference to the healthcare of patients? If so, my client can offer exceptional careers for exceptional people. Based on an established Bioscience campus in Cambridge, you will have the opportunity to work with smarter science, unique technologies and highly experienced scientific leaders.

My client is looking for an Associate Director of Regulatory Affairs to join their team. In this role you will have the opportunity to join a diverse business and be at the heart of the science making a difference in the development of antibodies.

The role is to help drive the rapid development of new therapeutic antibodies within inflammation and immuno-oncology. This role will provide exposure to regulatory affairs within the US and EU.

Key responsibilities:
Provide regulatory affairs guidance and proactive, practical hands-on input to achieve the required authorisations for clinical trials.
Regulatory affairs activities with focus on regulatory compliance for clinical trials
Develop or establish working relationships with third party partners in industry as appropriate to clinical research programmes and business plans
To communicate progress and identify risks and issues arising on regulatory issues
Contribute to a range of project teams, as required

Job Requirements
Bachelors degree in a relevant life sciences discipline
Significant industry experience of early-phase clinical trials (ideally within biologics)
Expertise within EU markets (US would be highly advantageous)
Expert level of knowledge in pre-authorisation regulatory affairs
Exceptional communication, collaboration and influencing skills
Maintain a high standard of professionalism when representing the Company, both internally and externally

If you can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to sophie@regulatoryprofressionals.com or call Sophie on 01189 522 797. We endeavour to come back to you within 24 hours of CV submission.