Remote Regulatory Affairs Lead – Post‑Approval Strategy

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

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, vision benefits

PTO

401(k) plan

Life & AD&D coverage

Parental leave

On-site lunches

Job summary

Orca Bio is seeking a Senior Director of Regulatory Affairs to lead the regulatory function as the company’s senior regulatory expert. You will partner with the CMO to shape regulatory strategy, manage health-authority engagements, and oversee post-approval lifecycle activities.

With a focus on post-approval operations, labeling, and lifecycle maintenance, you will guide the Regulatory Affairs team and coordinate with Quality and cross-functional partners to ensure readiness for future programs

Qualifications

• Bachelor's degree in life sciences or related field.
• 10+ years in regulatory affairs with strong US regulatory experience.
• Experience with EMA and global health authorities.
• Experience leading post-approval regulatory activities, including lifecycle management.
• Proven leadership of high-performing teams.
• Excellent written and verbal communication with strong project management skills.

Responsibilities

• Lead Regulatory Affairs function and team; advise executive leadership on strategy, health-authority engagement, lifecycle planning, and regulatory readiness.
• Develop regulatory strategy in partnership with executive leadership and execute agreed priorities.
• Lead post-approval regulatory execution, including supplements, variations, annual reports, and commitments.
• Oversee labeling reviews and promotion material compliance through cross-functional review.
• Lead interactions with FDA, EMA, and other authorities; coordinate with Quality on inspections and commitments.
• Assess regulatory risks and provide clear recommendations and paths forward to leadership.
• Collaborate with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams to support current and future programs.
• Maintain audit-ready regulatory records and systems.

Skills

Regulatory leadership

US regulatory experience

Executive communication

People leadership

Project management

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Job description

Orca Bio is seeking a Senior Director of Regulatory Affairs to lead the regulatory function as the company’s senior regulatory expert. You will partner with the CMO to shape regulatory strategy, manage health-authority engagements, and oversee post-approval lifecycle activities.

With a focus on post-approval operations, labeling, and lifecycle maintenance, you will guide the Regulatory Affairs team and coordinate with Quality and cross-functional partners to ensure readiness for future programs