Director Global Regulatory Affairs Rare Diseases
Hobson Prior are collaborating with a brilliant biopharmaceutical organisation who are looking for an individual to join their team on a permanent basis located either in Paris or in London. This role that is currently available is for a Director of Global Regulatory Affairs in Rare Diseases. For more information, please get in touch now!
Please note that to be considered for this role you must have the right to work in this location.
- Responsible for developing, implementing and executing regulatory methods actions on an international scale.
- Review the development goals and current plan versus new key discoveries and regulatory needs, working alongside R&D, franchise, operations and project teams to guarantee plan adaptation when required.
- Outline and implement method for regulatory consultation such as scientific advice, FDA planned meetings, regulatory boards, etc.
- For this role, you will be accountable for performing regulatory due diligence assessment on external prospects.
- Guarantee that outsourced actions are delivered within budget and a timely manner, as well as recognise and alert management concerning any service problems.
- Form efficient relationships with international regulators for professional communications on the company's method in connection to allocated products/disease areas.
- Any other assigned duties.
- Educated to a degree level in a scientific field.
- Leadership capabilities.
- Demonstrable experience in regulatory affairs.
- Familiarity with submissions, pre-submissions, early development projects.
- Acquaintance working within early product development on an international scale, such as DA/EMA, etc.
- Able to see prospects and revise process or approach to reduce obstacles for others to be capable of delivering more.
- Communication skills both verbally and in writing.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.