Your new company
A global biotech looking for an experienced Regulatory Affairs Manager to join their established EU Regulatory Affairs team.

Your new role

• Assess new materials and legislation for regulatory impact.

• Manage documentation, licences, and supplier records

• Support the creation of strategy and execution plans and manage regulatory submissions (e.g., clinical trials and marketing applications).

• Provide critical support in developing global regulatory strategy, planning and execution of global investigational submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).

• Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans.

What you need

• Extensive relevant experience in a scientific environment including demonstrable experience in an international role.
• Strong negotiation and communication skills with ability to challenge
• Excellent interpersonal skills and strong team player
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
• Good regulatory and/or technical writing skills
• Good leadership skills, with ability to motivate, coach and mentor
• Good presentation skills