Regulatory Affairs Director

I have partnered with a leading technical and scientific consulting group who work with a variety of Pharmaceutical and Biotechnology companies across the globe.

This role is remote and the HQ is based in England.

The Regulatory Affairs Professional provides development stage advice to internal staff and to clients for a broad range of programmes. They will provide the following expertise based services:

• Lead EMA procedures including orphan applications, PIPs and MAAs
• Point of contact for agency interaction
• Provide expert EU regulatory strategy
• To be a client lead
• Provide leadership in scientific advice meetings at national agencies and EMA
• Project management/lead responsibilities
• Client facing with strong communication skills, willing to travel
• To assist the senior management team by providing leadership support to a team of internal consultants and their clients
• To assist the company in providing regulatory knowledge to business development colleagues during bid defence

Regulatory Affairs Director / Associate Director

• Demonstrable experience in leading the agency, writing and strategy coordination for scientific advice, orphans and PIPs
• Degree or higher in a scientific disciplines
• 5+ years broad & deep European regulatory affairs experience in development stage programmes
• Demonstrable experience in liaising and negotiating with regulatory authorities and point of contact with EMA
• Demonstrable experience in centralised MAAs, orphan applications and PIPs
• Strong understanding of the regulatory environment including guidelines
• Ability to lead team members in a matrix management environment
• Ability to work under pressure and achieve timely submission and regulatory approval
• Confident speaker about regulatory challenges in EU and global pharmaceutical development, and able to communicate effective solutions to clients