[Hiring] Senior Director, Regulatory Affairs @Orca Bio

Role Description

The Senior Director of Regulatory Affairs is Orca Bio's functional Head of Regulatory Affairs, leading the Regulatory Affairs function and serving as the company's primary regulatory subject-matter expert and advisor. The incumbent will assist the C-Suite to develop and prepare for regulatory strategy which should be agreed by the executive leadership. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves.

• Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader.
• Advise executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements.
• Develop and recommend regulatory strategy in partnership with executive leadership.
• Lead near-term post-approval regulatory execution, including commercial-stage supplements and variations.
• Provide ongoing compliance support for the commercialized product.
• Lead ongoing interactions and correspondence with the FDA, EMA, and other health authorities.
• Assess significant regulatory, policy, and health-authority issues, providing executive leadership with clear recommendations.
• Partner closely with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams.
• Maintain and continuously improve regulatory affairs systems, trackers, and records.
• Lead and develop the Regulatory Affairs team.

Qualifications

• Bachelor’s degree in life sciences or a related discipline required.
• 10+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry.
• Track record of participating in approval of a commercial-stage product strongly preferred.
• Demonstrated success managing post-approval regulatory activities.
• Working knowledge of drug development and commercialization requirements.
• Proven people leader with a track record of building, coaching, and developing high-performing teams.
• Excellent written and verbal communication skills.
• Strong project management and organizational skills.

Requirements

• Experience working with global health authorities such as the EMA.
• Experience in hematology, oncology, cell therapy, or bone marrow transplant preferred.

Benefits

• Annual salary range: $250,000 - $300,000.
• Eligible for pre-IPO equity and annual bonus.
• Competitive medical, dental, and vision benefits.
• PTO and 401(k) plan.
• Life and accidental death and disability coverage.
• Parental leave benefits.
• Subsidized daily lunches and snacks at on-site locations.