Hobson Prior are seeking an Associate Director of Regulatory for a biotechnology company based in Hertfordshire. This role will participate in the development, review and execution of regulatory strategy within the regulatory sub-team and will take the lead delivering regulatory activities/submissions necessary to support global product development and registration.
- Lead the preparation of high-quality regulatory documents and dossiers including, IMPD/CTA/IND, FDA briefing packages, scientific advice briefing packages, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions and other regulatory filings.
- Deliver strategic and tactical input to project and regulatory sub-teams in all aspects of regulatory affairs.
- Represent as the regulatory contact point Gyroscope’s interactions with regulatory authorities.
- Manage external vendors (consultants, CROs and regulatory authorities).
- Contribute to the growth of the regulatory affairs function, supporting GxP compliance and inspections.
- Remain expert and up to date on global regulatory requirements for ATMPs.
- Keep up-to-date of relevant regulatory intelligence and ensuring this is effectively disseminated within the organisation.
- Assist with training of staff in regulatory matters as required.
- Work effectively and collaboratively in a matrix environment.
- Strong oral and written communication, interpersonal, analytical, and computer skills.
- Proactive, a fast-learner and flexible.
- BA/BS in the life sciences or equivalent work experience is required (advanced degree is advantageous).
- Minimum of 5-8 years’ experience [AB1] in regulatory affairs, with experience in biotechnology/biologicals (particularly ATMPs - development gained in industry or service provider environments).
- Experience of European and US regulatory affairs e.g. CTA/IND/MAA/BLA preparation and submissions.
- Knowledge and understanding of US, EU and ICH guidelines and experience of working to GxP. Understanding of in vitro device/companion diagnostic regulations is a bonus.
- Experience of planning meetings with the FDA, the EMA and European national regulatory authorities.
- Demonstrated capability to support creation and execution of effective regulatory strategies and developing solutions for solving regulatory problems.
- A track record of successful interactions and submissions with regulatory agencies including EMA, European national agencies and the FDA and vendors/consultants.
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.