Hobson Prior are looking for an EU Regulatory Science Lead to strengthen the European Regulatory Affairs department at a leading biopharmaceutical company on a permanent basis.
Develops and implements the regional regulatory strategy and plan consistent with the business objectives.
Serve as the primary regional point of contact for the GRL and other relevant parties.
Responsible for enabling and organising the regulatory regional product team in collaboration with GRL to ensure that objective priorities are met.
Accountable for confirming that the regional regulatory strategies have been negotiated (if appropriate) with the regional health authorities and that the regulatory risks have been identified and mitigated.
Responsible for ensuring that the overall plans for the regional regulatory strategy are effectively discussed with, endorsed by and communicated throughout the organisation to the relevant parties.
Coordinate the regional submission team.
Deliver regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.
Maintain required databases, systems and processes.
Formulate and distribute regulatory strategic and operational plans for assigned projects.
Contribute in the development of regulatory standards, efficient processes and SOPs.
Continually monitor external regulatory environment, new guidelines and legislation.
Excellent interpersonal and communication skills.
Ability to build effective partnerships.
Strategic and results focused.
Strong Project planning and management skills.
Capability to be flexible and adaptable where required.
Educated to degree level as a minimum.
At least 8 years' experience within Regulatory Affairs.
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.