Chief Regulatory Officer

Biodexa Pharmaceuticals PLC (NASDAQ: BDRX) is a clinical-stage biopharmaceutical company developing innovative products focused on the treatment of prevention of rare/orphan gastrointestinal cancers. The company’s leading development programs are eRapa, a Phase 3 product targeting familial adenomatous polyposis (FAP) and MTX
240, a Phase 1 ready, novel molecular glue designed to target gastrointestinal stromal tumors (GIST). Biodexa Pharmaceuticals is also working on a groundbreaking treatment for type 1 diabetes.

Reporting to the Chief Medical Officer, this is a part-time (2-3 days a week) hybrid role located in Texas, United States. As the Chief Regulatory Officer, you will oversee at a strategic level to ensure compliance with regulatory requirements, lead all regulatory submissions, and evaluate the potential impact of regulatory changes on the company’s programs. You will work collaboratively with cross-functional teams to align regulatory objectives with the company’s goals and support the preparation for key clinical trials and product approvals.

• 10 plus years of relevant regulatory affairs experience
• Extensive knowledge and expertise in Regulatory Documentation and Regulatory Submissions
• Strong understanding of Regulatory Compliance and navigating complex Regulatory Requirements
• Proven leadership in Regulatory Affairs, including managing interactions with regulatory agencies
• Detailed knowledge of requirements for accelerated and conditional approvals and Priorlty Review Vouchers preferred.
• Experience of orphan drug development preferred
• Ability to develop and execute regulatory strategies for clinical-stage biopharmaceutical organizations
• Strong analytical, communication, and organizational skills
• Doctorate or advanced degree in a relevant life sciences or related field is preferred