Regulatory Affairs Consultant

工作内容

Hobson Prior are currently looking for a Regulatory Affairs Consultant to join a fantastic CRO on a permanent basis located in Wavre with the possibility to work remotely. Our client is focused on delivering their expertise to modernise clinical development in a quicker and more cost-effective way.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will report into a Senior Manager, Regulatory Affairs in France.
• Work alongside a fast paced, dynamic and collaborative group.
• For this role, you will be responsible for managing and submitting marketing authorisation dossiers for Belgium-Netherland-Luxembourg (Benelux).
• Formulate a plan for the submission and seeking procedural slots.
• Draft the modules, formatting, and data integrity checks.
• Publish and portal submission.
• Within this role, you will be working with a very large and interactive group, along a cross region communication with peers, management, clients and project teams.
• You will have the opportunity for career path progression from a Regulatory Affairs Consultant to Senior Regulatory Affairs Consultant to Principal, Regulatory Affairs Consultant. There is no set timescale for progressing.

Key Skills:

• Critical thinking and problem-solving skills.
• Proactive and self-motivated to get things done self-sufficiently.
• A strong communicator.
• Good attention to detail.
• Able to engage in collaborative functions.
• Solid leadership skills.

Requirements:

• A degree in the Life Sciences, Pharmacy or a Medicine related subject is essential. A M.Sc. or a PhD is advantageous but not essential to the role.
• Prior experience working in a CRO, Pharma or a Regulatory agency in the capacity as a Regulatory Affairs Consultant or Senior Regulatory Affairs Consultant specialising in MAA submissions.
• Must be able to speak English, French and Dutch.
• Capable of summarising regulatory guidelines and apply them appropriately.
• Great understanding of regulatory MAA Dossier submissions tasks and activities for the Benelux region of at least 3-5 years.
• Capable of participating in discussion on regulatory strategies.
• Sturdy people management experience.
• Good client facing experience, approach and communication skills are essential. Will need to be able to problem solve client issues and manage client relationships.

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.