Job Title: Regional Regulatory Lead

An exciting opportunity has arisen for a Biotechnology business who are looking for someone to join their growing team. The Regional Regulatory Liaison is responsible for implementing regulatory strategies for the company pipeline, providing essential regulatory guidance and oversight for assigned products.

The role operates within a multinational and global setting, requiring the candidate to contribute to developing the network and expanding the knowledge base of the GRA team.

Key Responsibilities

• Under supervision from a senior team member and/or Line Manager, defines and implements regulatory strategies for assigned products and regions
• Actively participates in cross-functional teams in order to define the development and regulatory strategies for assigned products
• Identifies regulatory requirements and trends across areas of responsibility and provides regulatory guidance and expertise to regions, and global development teams, as needed.
• As an active hands-on member, participates in multi-disciplinary teams in order to define the development and regulatory strategies of any assigned early and late stage development programs.
• Coordinates the preparation, review, and submission of health authority documents as required including initial marketing authorisation applications, responses to Agencies’ questions and requests, meeting requests, briefing packages, annual reports, etc.