Senior Director, Regulatory Affairs

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🕒 Setembro 23

🏄 California – Remoto

🏄 California – Remote

💵 $250.000 - $300.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Orca

SiteLinkedInTodas as Vagas

11 - 50 funcionários

💳 Fintech

₿ Cripto

💸 Finanças

Fintech • Crypto • Finance

Orca é uma plataforma que facilita a negociação e a provisão de liquidez aproveitando a velocidade da tecnologia blockchain Solana na rede Ethereum. Permite que os usuários negociem, gerenciem portfólios e conectem suas carteiras na rede Eclipse. Projetada para fornecer uma experiência sem interrupções, combinando o ecossistema do Ethereum com as capacidades de processamento rápido do Solana, a Orca tem como alvo usuários interessados em negociações de criptomoedas e soluções de liquidez.

Descrição

• Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader. • Advise the C-Suite and executive leadership on regulatory strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements. • Develop and recommend regulatory strategy with executive leadership and execute agreed strategic priorities. • Lead post-approval regulatory execution, including commercial-stage supplements and variations, annual reports, lifecycle maintenance submissions, labeling updates, and post-marketing commitments. • Provide compliance support for the commercialized product, including Regulatory Affairs review of labeling, promotional, advertising, and other commercial materials. • Lead interactions and correspondence with the FDA, EMA, and other health authorities. • Partner with Quality on inspections, regulatory commitments, and follow-up actions. • Assess significant regulatory, policy, and health-authority issues and provide recommendations to executive leadership. • Partner with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams on regulatory deliverables and pipeline readiness. • Maintain and improve regulatory affairs systems, trackers, and audit-ready records. • Lead and develop the Regulatory Affairs team and keep executive leadership informed on status, risks, and timelines.

🎯 Requisitos

• Bachelor’s degree in life sciences or a related discipline required. • 10+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including deep U.S. regulatory experience and meaningful experience working with global health authorities such as the EMA. • Demonstrated success managing post-approval regulatory activities, including commercial-stage supplements, labeling changes, annual reports, and post-marketing commitments. • Working knowledge of drug development and commercialization requirements, including clinical trial requirements, CMC, manufacturing, quality, post-marketing surveillance, and promotional review. • Proven people leader with a track record of building, coaching, and developing high-performing teams. • Excellent written and verbal communication skills, with the ability to proactively engage and inform executive leadership and translate complex regulatory matters into clear, actionable recommendations; strong project management and organizational skills suited to a hands-on, detail-oriented, small commercial-stage biotech environment. • Track record of participating in approval of a commercial-stage product strongly preferred; experience in hematology, oncology, cell therapy, or bone marrow transplant preferred.

🏖️ Benefícios

• 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