Senior Director, Regulatory Affairs

Job not on LinkedIn

🔥 9 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $250k - $300k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 6%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Orca

WebsiteLinkedInAll Job Openings

11 - 50 employees

💳 Fintech

₿ Crypto

💸 Finance

Fintech • Crypto • Finance

Orca is a platform that facilitates trading and liquidity provision by leveraging the speed of Solana blockchain technology on the Ethereum network. It allows users to trade, manage portfolios, and connect their wallets on the Eclipse network. Designed to provide a seamless experience by combining Ethereum's ecosystem with Solana's rapid processing capabilities, Orca targets users interested in cryptocurrency trading and liquidity solutions.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ 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