CMC Regulatory Affairs Consultant - East Anglia

Cambridge

CMC Regulatory Affairs Consultant - East Anglia - Pharmaceutical - Consultancy

An exciting opportunity has arisen for an experienced CMC Regulatory Affairs professional to join a dynamic consultancy providing services to the Pharmaceutical industry based in Cambridgeshire in East Anglia.

This expanding client focused company has a worldwide presence, it specializes in product development programs offering services in Regulatory Affairs, Quality Assurance and early stage Clinical Research.

As the CMC Regulatory Affairs Consultant you will report to the Head of Regulatory Affairs and you will provide regulatory and advanced therapy expertise. You will be responsible for the regulatory preparation of clinical trials and marketing authorization applications (MAA’s) for the EU and US, reviewing CMC plans against EU and US guidelines, writing regulatory documents, liaising with EU and US regulatory authorities and contributing to project development.

Ideally you will possess a life science degree, have significant CMC regulatory affairs experience within biotechnology products and it would be highly advantageous to have previous experience of advanced therapy products and of dealing with EU and US regulatory authorities. You should be organized, customer focused, have an excellent commercial awareness, a dynamic approach and be a team player.

This is an exceptional opportunity within a career driven company offering a stimulating and rewarding working environment and excellent benefits including competitive salaries, a pension scheme, a generous holiday entitlement, private healthcare and death in service.

Key Words – CMC, Biotechnology, Healthcare, Pharmaceutical, Clinical, Regulatory Affairs, Regulatory Affairs Consultant, Regulatory Affairs Manager, Senior Regulatory Affairs Executive, Regulatory Affairs Director, Cambridgeshire, East Anglia

For further information on the role or company please contact myself, Amie Adams at Paramount Recruitment on 0121 616 3473.


Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

CMC, Biotechnology, Healthcare, Pharmaceutical, Clinical, Regulatory Affairs, Regulatory Affairs Consultant, Regulatory Affairs Manager, Senior Regulatory Affairs Executive, Regulatory Affairs Director, Cambridgeshire, East Anglia