Regulatory Affairs Consultant

Hobson Prior are looking for a Regulatory Affairs Consultant to join a consultancy in Cambridge who are focused on supporting the development of new medicines to benefit patient's well-being. You will join the Regulatory team of 8-10 people and have a focus of delivering on biological focused requirements for 2-3 of the organisation's clients.

Job Responsibilities:

• Take client ownership of the projects and will need the ability to come in and hit the ground running.
• Work as a 'Regulatory Generalist' responsible for Regulatory authoring and compiling of dossiers such as CTA, PIPs and providing scientific advice. (CMC authoring could also be included if a candidate is strong in this area, such as IMPD's)
• The candidate will also be tasked with leading compilation of scientific advice briefing packs for the EMA (and possibly FDA).
• Responsibility with project managing internal and external stakeholders to ensure excellent customer service is being deliver to Boyd end clients.
• Provide strategic and tactical input to project and regulatory sub-teams in all aspects of regulatory affairs.

Key Skills:

• Must have strong communication skills and needs to be happy working with a small team in a fast-paced environment.

Requirements:

• At least 5+ years of experience within Regulatory Affairs, preferably working as a consultant.
• Biological product experience is strongly preferred. (ATMP would be a real bonus).
• Previous experience either working with a consultancy/CRO environment or have a strong understanding of how to deliver good client service if coming from a pharma/biopharma background.
• Must be a strong Regulatory writer with a proven track record of working on documents such as CTA's, PIP's, Scientific Advice.
• Must have EMA contact exposure.
• Experience working on CMC dossiers will be a bonus.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.