Senior Director, Regulatory Affairs

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee the Regulatory Affairs function at Orca Bio and act as the senior regulatory leader within the organization.

• Provide guidance to the C-Suite and executive leadership regarding regulatory strategy, engagement with health authorities, lifecycle planning, associated risks, and new requirements.

• Collaborate with executive leadership to formulate and propose regulatory strategies and implement the agreed-upon strategic priorities.

• Direct post-approval regulatory activities, which include managing commercial-stage supplements and variations, annual reports, lifecycle maintenance submissions, labeling updates, and commitments following marketing.

• Offer compliance assistance for commercialized products, encompassing Regulatory Affairs review of labeling, promotional content, advertising, and other commercial materials.

• Manage communications and engagements with the FDA, EMA, and other health authorities.

• Work alongside Quality on inspections, regulatory commitments, and necessary follow-up actions.

• Evaluate significant regulatory, policy, and health authority issues, providing recommendations to the executive leadership team.

• Collaborate with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams on regulatory deliverables and readiness for the pipeline.

• Maintain and enhance regulatory affairs systems, trackers, and ensure audit readiness of records.

• Lead and develop the Regulatory Affairs team while keeping executive leadership updated on progress, risks, and timelines.

⛳️ Requirements

• A Bachelor’s degree in life sciences or a related field is required.

• A minimum of 10 years of regulatory affairs experience within the biotechnology or pharmaceutical sector, including extensive U.S. regulatory experience and substantial interaction with global health authorities like the EMA.

• Proven success in managing post-approval regulatory activities, including commercial-stage supplements, labeling modifications, annual reports, and commitments post-marketing.

• Comprehensive understanding of drug development and commercialization necessities, encompassing clinical trial requirements, CMC, manufacturing, quality assurance, post-marketing surveillance, and promotional review.

• Established people leader with a history of building, coaching, and nurturing high-performing teams.

• Exceptional written and verbal communication skills, capable of proactively engaging with executive leadership and translating intricate regulatory issues into clear, actionable recommendations; strong project management and organizational abilities suited for a hands-on, detail-oriented, small commercial-stage biotech setting.

• A strong preference for candidates with a history of participating in the approval of a commercial-stage product; experience in hematology, oncology, cell therapy, or bone marrow transplant is also preferred.

🏝️ Benefits

• Pre-IPO equity

• Annual bonus

• Medical benefits

• Dental benefits

• Vision benefits

• PTO

• 401(k) plan

• Life and accidental death and disability coverage

• Parental leave benefits

• Subsidized daily lunches and snacks at on-site locations