Associate Director, Regulatory Affairs

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Accountable for the creation and execution of UK regulatory strategies for products.

• Direct the UK Regulatory Affairs team to handle regulatory elements of compounds.

• Partner with essential internal stakeholders on the UK Marketing Authorization Application (MAA) strategy.

• Oversee the preparation and content of regulatory dossiers for the UK MAA.

• Supervise communications, submissions, and approvals from regulatory bodies.

• Serve as the Regulatory Affairs liaison within the UK Leadership team, contributing to UK business strategy.

• Proactively identify and mitigate regulatory risks while staying informed on regulatory intelligence.

• Guide junior team members and represent BeOne at UK industry meetings.

⛳️ Requirements

• A Bachelor’s degree is required; an advanced degree is preferred.

• At least 8 years of experience in the biotechnology or pharmaceutical sector.

• A minimum of 8 years in a Regulatory role.

• Experience with MHRA regulatory procedures is essential.

• Strong understanding of the drug development process and UK regulatory standards.

• Recent experience with oncology products, MAAs, Orphan Drug Designation (ODD), and Pediatric Investigation Plans (PIP) is preferred.

🏝️ Benefits

• Health insurance

• Flexible work arrangements

• Professional development opportunities