Hobson Prior are looking for a Regulatory Affairs Associate Director / Director to join a leading pharmaceutical consultancy who are committed to providing high quality strategic and operational services to the pharmaceutical and biotechnology industry.
- Responsible to manage the EMA procedures, this will include orphan applications, PIPs and MAAs.
- Support the company in providing regulatory knowledge to business development colleagues during bid defence.
- Offer expert EU regulatory strategy.
- Represent as the first point of contact for agency interaction.
- To be a client lead.
- Provide leadership in scientific advice meetings at national agencies and EMA.
- Project management/lead responsibilities.
- Client facing with strong communication skills, willing to travel.
- Support the senior management team by providing leadership support to a team of internal consultants and their clients.
- Innovative and pragmatic problem solver.
- Attention to detail.
- Confident speaker about regulatory challenges in the clinical development of biological and next generation technologies and approaches to finding solutions.
- Strong communicator with the ability to influence and lead team members.
- Completer-finisher able to provide decisive leadership in a project team setting.
- Ability to work under pressure and achieve timely submission and regulatory approvals.
- Degree or higher in Chemistry, Biochemistry, Biology or related scientific disciplines.
- A minimum of 5+ years broad & deep European regulatory affairs experience with demonstrable experience in liaising and negotiating with regulatory authorities and point of contact with EMA.
- Demonstrable experience in centralised MAAs, orphan applications and PIPs.
- Strong understanding of the regulatory environment including guidelines.
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.