Regulatory Affairs Senior Manager

Hobson prior have an exciting opportunity for a Regulatory Affairs Associate Manager join a multinational biopharmaceutical company. Within this role you will be focused on supporting development activities and managing teams in the area of General Medicine

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

Key Responsibilities:

• Further build the organisations regulatory profile in Europe and serve as a resource for European knowledge for the global regulatory and development teams.
• Liaise with clinical teams in study start up and maintenance activities by leading all associated regulatory activities, including but not limited to submissions, addressing agency queries, managing compliance issues.
• Represent the company in interactions with multiple CROs for a broad range of complex late stage clinical studies.
• Take advantage of the various regulatory systems and processes, in particular the application of innovative regulatory pathways to our development products.
• Provide leadership on both late and early-stage clinical development related process and strategy to ensure timely study conduct end to end.
• Monitor emerging legislation and guidance and contribute to ensuring company-level awareness and compliance.
• Provide support on all aspects related to the development of novel therapeutics such as paediatric investigational plan, scientific advice and MAA related activities.

Requirements:

• Scientific degree, preferably a Masters.
• Fluent English speaking.
• 8+ years' experience in Regulatory.
• Previous experience working with products in development phases is required.

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.