Regulatory Affairs Consultant, Vaccines – US/UK/IN opportunities
To meet the increasing demand from our clients for regulatory assistance with their vaccines and biologics portfolios, G&L 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 consultative 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 who are working on US FDA meetings – including all activities e.g. coordinate, schedule, prepare all documents, attend the meetings
- Managing a team who are responsible for all regulatory CMC and clinical documents post-licensure for US licensed products
- Managing a team who are tasked with writing a US BLA for submission to FDA (a hands-on approach and recently working knowledge would be preferable).
- Our team of consultants are expected to be ambassadors for G&L – working directly with clients and Health Authorities – so therefore we really value communication skills and the art of negotiation and diplomacy.
- All our staff are encouraged to have the confidence to speak their mind and suggest new ideas. All our consultants are expected to act as mentor to junior staff, contributing to the development of graduate and junior training programmes.
- Above all, our company is all about our people – so you should have a passion for meritocracy, recognition and development.
- We hope that you will feel excited about making suggestions or challenging existing methodologies! G&L’s reputation has been built on our customer service and client-focus – so any ideas that will help us stay ahead of the curve are encouraged!
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