Hobson Prior are looking for a Regulatory Affairs Expert to join a world-wide biopharma organisation on a contract basis in Brussels. Our client specifically specialises within neurology and immunology and as the Regulatory Affairs Expert you will support the Regulatory Lead in planning and executing the necessary regulatory activities to progress our clients project portfolio with the aim of obtaining marketing authorizations globally.

Job Responsibilities:

• You will act as the contact person for assigned responsibilities on the product, in alignment with Regulatory Lead.
• Assume responsibilities for contact with 3rd party partners (mainly CROs), building strong relationships for assigned project(s), in line with the Regulatory Lead.
• Accountable for providing regulatory expertise and strategy, in alignment with the Projects
• Support and deliver quality regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.
• Ensure that all documents and information are adequately captured in a timely fashion in the applicable systems (document management, databases, etc).
• Prepare and communicate regulatory strategic and operational plans for assigned projects.
• Maintain awareness of external regulatory environment, new guidelines and legislation.

Key Skills:

• Strategic and results focused - ability to overcome obstacles and achieve key outcomes.
• Strong Project planning and management skills, being able to perform risk assessments, anticipating problems and providing creative solutions.
• Analytical - logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions.
• Integrity - overriding commitment to integrity and high standards in self and others.
• Flexibility and adaptability - Decides what to do based on the situation. Changes behaviour or approach to fit the situation or the person. Works effectively in ambiguous situations.

Requirements:

• Experience of EU regional regulatory procedures and legislation related to drug development and clinical trial applications. From 5 to 10 years of global experience preferred in this field.

Apply now:

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.