Senior Regulatory Consultant

A new vacancy has risen for a Senior Regulatory Consultant to join a consultancy firm who specialises in European regulatory affairs, quality systems and compliance for products. Our client is looking for a Senior Regulatory Consultant to join them on either a full time/part time basis in Cambridgeshire.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• To provide strategic and tactical input in development, post-approval and Life cycle management projects.
• Communicate with Regulatory Agencies, client companies and other stakeholders.
• Clinical Trial Applications (CTA).
• Input into technical documentation and process development.
• Marketing Authorization Applications (MAA).
• Active support of the organisation's ISO 9001:2015 Quality System.
• Project management.
• Resource Planning.
• Any other assigned duties.

Key Skills:

• Meticulous eye to detail and accuracy.
• Self-motivated, pro-active and capable of working independently, however can also work as part of a team.
• Excellent project management, organisation and multi-tasking skills.

Requirements:

• Requires a bachelor's degree in pharmacy, a life science or a biomedical discipline.
• In depth knowledge of the regulatory environment, guidelines and practice within EU.
• Breadth of regulatory experience in drug development, MAA approval and post-licensing (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas).
• Experience with EU regulatory procedures (Clinical Trial Submissions, CP, MRP, national).
• Experience in the clinical development and/or biotech sectors are admirable.
• Excellent English and written and oral communication skills.
• Computer literacy.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.