Director / Senior Director / Executive Director, Regulatory Affairs

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations, strengthening responsible execution, improving decision-making, and supporting sustainable growth within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Lead regulatory submissions and manage submission activities with minimal oversight for assigned oncology development programs
• Collaborate with CROs to ensure timely and accurate regulatory submissions, enhancing submission tracking
• Develop and execute global regulatory strategies aligned with corporate objectives and development timelines
• Facilitate regulatory planning for significant development milestones, coordinating with cross-functional teams
• Serve as the primary regulatory representative on development teams, providing strategic contributions to clinical documents and regulatory correspondence

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred
• 10-12 years of regulatory affairs experience in biotechnology or pharmaceuticals, specifically in oncology
• Experience leading regulatory submissions for oncology programs from early-phase to registration
• Demonstrated ability to manage direct reports or mentor within a regulatory capacity
• Strong knowledge of FDA, EMA, ICH, and global regulatory requirements applicable to oncology

Pay

$210,000 – $275,000 annually

Benefits

• Market-competitive total rewards package including base pay and performance bonuses
• Company equity options as part of the compensation structure
• Comprehensive health benefits to support employee well-being