Regulatory Affairs Director – Expanded Access Programs

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

📋 Description

• Transform the company's and RA/PV strategy into comprehensive regulatory plans tailored for various programs and regions.

• Facilitate the execution of Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiatives.

• Manage multiple regulatory programs concurrently, ensuring adherence to timelines, quality benchmarks, and client expectations.

• Identify and proactively address cross-program risks, dependencies, and resource limitations.

• Mentor, coach, and develop Regulatory Affairs Managers and senior team members.

• Collaborate closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain teams.

• Advocate for standardization, consistency, and scalability within regulatory processes.

• Serve as a senior contact point for clients regarding regulatory issues.

⛳️ Requirements

• An advanced degree in life sciences, pharmacy, or a related discipline.

• Extensive experience in Regulatory Affairs within pharmaceutical, biotechnology, or CRO settings.

• Demonstrated capability in managing multiple programs and intricate regulatory portfolios.

• In-depth understanding of global regulatory frameworks (EAP, clinical trials, or similar contexts).

• Proven leadership experience in team management and talent development.

• Exceptional skills in stakeholder management and communication.

🏝️ Benefits

• Equal Opportunity Employer

• Commitment to diversity and inclusion