Regulatory Affairs Director — Post-Approval Strategy

Medium; Menlo Park (CA); On-site; USD 250,000 - 300,000; Full time

Benefits offered by this job

On-site meals

Job summary

Orca Bio, a leading biotechnology company, seeks a Senior Director of Regulatory Affairs to lead regulatory strategy and execution. You will work with the CMO and executive leadership to shape regulatory pathways for post-approval operations and future development programs.

You will mentor a growing team and collaborate across Clinical, CMC, Quality, and Commercial groups to ensure timely submissions, lifecycle management, and readiness for global expansion.

Qualifications

• Bachelor's degree in life sciences required.
• 10+ years regulatory affairs experience in biotech/pharma.
• Experience with US FDA and global authorities (EMA).
• Track record leading regulatory teams.
• Experience in post-approval regulatory activities.

Responsibilities

• Lead Regulatory Affairs function and serve as senior regulatory leader, advising on strategy and health-authority engagements.
• Develop regulatory strategy with executive leadership and own execution of priorities across the organization.
• Oversee post-approval regulatory execution, including submissions, labeling updates, and lifecycle maintenance.
• Provide ongoing compliance support for the commercial product and cross-functional reviews.
• Lead interactions with FDA, EMA, and other authorities and prepare for major engagements.

Skills

Regulatory leadership

Regulatory strategy

Communication

Project management

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Job description

Orca Bio, a leading biotechnology company, seeks a Senior Director of Regulatory Affairs to lead regulatory strategy and execution. You will work with the CMO and executive leadership to shape regulatory pathways for post-approval operations and future development programs.

You will mentor a growing team and collaborate across Clinical, CMC, Quality, and Commercial groups to ensure timely submissions, lifecycle management, and readiness for global expansion.