Regulatory Affairs Consultant, Vaccines – Global opportunities

To meet the increasing demand from our clients for regulatory assistance with their vaccines and biologics portfolios, we are expanding our global team. As a consultant at G&L, you will have the opportunity to work across a broad spectrum of client projects which includes drug development to post-approval lifecycle maintenance, for both small and large molecules. You will work across multiple therapy areas, in a progressive and rapidly expanding specialist consultancy, amongst colleagues who we consider to be the best in the business!

Our ideal candidates should have the following types of experience:

• Extensive Biotech and Vaccine experience
• Ability to think strategically and critically to evaluate risk and to deliver on regulatory projects
• Ability to work consultatively and strategically within often complex, business critical and high-profile client programs.
• Experience in leading Health Authority interactions
• Extensive knowledge of regulatory affairs covering multiple therapeutic areas in early and/or late development
• Proven track record of regulatory drug development, including product approval/launch
• Broad CMC background

Duties may include but are not limited to:

• Being the project lead for a team of G&L consultants who are working on developing or already-licensed human vaccines within various therapeutic areas
• Managing a team  working on US FDA meetings – including all activities e.g. coordinate, schedule, prepare all documents, attend the meetings
• Managing a team  responsible for all regulatory CMC and clinical documents post-licensure for US licensed products
• Managing a team  tasked with writing a US BLA for submission to FDA (a hands-on approach and recently working knowledge would be preferable).