Hobson Prior is seeking a Global Regulatory Affairs Principal Specialist. This role involves creating and implementing innovative strategies to speed up growth and deliver new products. You will be responsible for obtaining and maintaining marketing authorizations for complex products and communicating regulatory requirements. You will also provide advice to managers and manage regulatory activities for a specific portfolio of products/projects.

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

Key Responsibilities

• Develop and initiate complex regulatory project plans.
• Identify and prioritize areas of regulatory risk.
• Keep track of relevant regulatory requirements.
• Create and maintain complex regulatory files in a format that meets requirements.
• Provide regulatory advice and strategic guidance to project teams, focusing on innovation and acceleration.
• Respond to complex questions from regulatory authorities within strict timelines.
• Compile and submit regulatory documents according to regulatory requirements in a timely manner.
• Manage complex regulatory activities relating to a specific portfolio of products/projects.
• Prepare, review, and approve labelling and SOP's.
• Lead or represent Regulatory Affairs in project teams.
• Provide guidance and coaching for areas of responsibility to lower level team members.

Requirements

• Knowledge of regulations.
• Strategic thinking.
• Innovation focused, especially on drug development and speed to market.
• Scientific knowledge.
• Project management skills.
• Ability to manage multiple projects and deadlines.
• Ability to multitask and prioritize.
• Interpersonal and communication skills.
• Strong negotiation skills.
• Ability to work effectively in a multinational/multicultural environment.
• Ability to identify compliance risks and escalate when necessary.
• Ability to work autonomously.
• Bachelor's degree or equivalent in a scientific discipline.

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.

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