Hobson Prior is currently seeking a Regulatory Liaison for a leading global biopharmaceutical company that has been inventing for life for more than a century. This role will be based in Brussels on a contract basis.
- Deliver strategic and operational regulatory support in preparation of the submission and during the review of new Marketing Authorisation Applications, variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements.
- Co-operating with the Regional Submission Planner to provide input and ensure alignment on submission plans.
- Working closely with Regulatory Operations to establish submission timelines of Module 1 components.
- Drafting and organizing the gathering of the module 1 components.
- Working closely with country Regulatory Affairs staff to ensure timely submission to national Agencies.
- Preparing the English Product Information (Summary of Product Characteristics, label and leaflet) in collaboration with Worldwide Product Labelling.
- Supervise and coordinate the local translation process to ensure efficient submission to EMA.
- Making sure of updates to regulatory databases.
- Keep up to date with EU procedural requirements and legislation.
- Demonstrates the ability to act as intermediary across boundaries.
- Can evaluate new ideas and proposed methods for practicality and ease of implementation.
- Has proven the ability to coordinate tasks with others for an efficient completion and to avoid setbacks.
- Demonstrates the ability to review regulatory documents for accuracy.
- Assesses activities and business processes across functions, identifies areas in need for improvement and leads efforts for solution design and implementation.
- Considers the recent innovations when formulating recommendations.
- Degree in life sciences.
- Knowledge of EU regulatory procedures and development of medicinal products in general would be preferred.
- Has the understanding of the end-to-end pharmaceutical lifecycle.
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.