Regulatory Affairs Leader - Post-Approval for Cell Therapy

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

Benefits offered by this job

Equity

Annual bonus

Benefits package

PTO

401(k)

Life insurance

Disability coverage

Parental leave

Lunch on-site

Job summary

Orca Bio in Menlo Park, CA, seeks a Senior Director, Head of Regulatory Affairs to lead regulatory strategy and lifecycle management for a commercial-stage biotech. This role reports to the Chief Medical Officer and guides post-approval operations, while preparing for future indications and global expansion.

You will collaborate with FDA/EMA, build and lead the Regulatory Affairs team, and provide clear recommendations to executive leadership on risks and opportunities.

Qualifications

• Bachelor’s degree in life sciences required and 10+ years in regulatory affairs in biotech/pharma.
• Experience with post-approval regulatory activities including labeling changes and lifecycle management.
• Strong communication and leadership skills with ability to influence executive leadership.

Responsibilities

• Lead Regulatory Affairs and serve as senior regulatory leader; advise executives on strategy and health-authority engagements.
• Develop and execute regulatory strategy with executive leadership across the organization.

Skills

Regulatory leadership

Communication skills

Project management

People leadership

Regulatory strategy

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Job description

Orca Bio in Menlo Park, CA, seeks a Senior Director, Head of Regulatory Affairs to lead regulatory strategy and lifecycle management for a commercial-stage biotech. This role reports to the Chief Medical Officer and guides post-approval operations, while preparing for future indications and global expansion.

You will collaborate with FDA/EMA, build and lead the Regulatory Affairs team, and provide clear recommendations to executive leadership on risks and opportunities.