Senior Director, Regulatory Affairs

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $211.2k - $281.2k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Develop and execute integrated U.S. regulatory strategies for assigned products and programs across clinical development, registration, post-approval commitments, and lifecycle management • Provide authoritative U.S. regulatory advice to global regulatory leaders, development teams, governance committees, and senior management • Assess strategic options, risks, trade-offs, and mitigation plans and integrate U.S. regulatory considerations into global strategies • Serve as the primary regulatory leader for FDA engagement, planning, leading, and negotiating formal and informal interactions • Oversee strategy, preparation, quality, and timely submission of INDs, NDAs, BLAs, supplements, amendments, meeting packages, briefing documents, responses to information requests, and other U.S. regulatory filings • Incorporate U.S. regulatory requirements and FDA expectations into clinical development plans, evidence-generation strategies, labeling plans, and commercialization and lifecycle decisions • Lead regulatory risk assessment and critical issue management, escalating significant risks and driving cross-functional alignment on mitigation and execution • Maintain expert knowledge of FDA regulations, guidance, policy developments, and precedents and evaluate portfolio implications • Build partnerships with Clinical Development, Medical, Safety, Biostatistics, Clinical Operations, CMC, Quality, Legal, Commercial, and other functions • Represent Regulatory Affairs on senior cross-functional teams and governance forums and communicate complex regulatory matters to stakeholders • Anticipate high-impact portfolio or program regulatory risks and direct mitigation, escalation, and risk-acceptance decisions • Shape regulatory practices, operating approaches, innovation, future-state organizational capability, procedures, and process improvements • Recruit, develop, coach, and retain regulatory talent; establish priorities and performance expectations • Provide direct and matrixed supervision, capability building, succession planning, performance management, and development of a high-performing U.S. regulatory organization • Represent the company in external industry forums and regulatory policy discussions as needed

🎯 Requirements

• 15+ years of experience in the pharmaceutical or biotechnology industry, including significant progressive experience in U.S. Regulatory Affairs and leadership of complex development programs • Bachelor’s degree in a scientific or health-related discipline required • Advanced scientific, medical, pharmacy, or regulatory degree preferred • Demonstrated leadership of complex U.S. regulatory strategies across multiple programs • Experience in both early- and late-stage oncology preferred • Demonstrated success as a U.S. regulatory lead with direct FDA interaction experience and significant regulatory accomplishments across development, registration, and lifecycle management • Expert knowledge of U.S. drug development regulations, guidance, policy trends, and submission requirements, including INDs and NDAs and/or BLAs • Experience with expedited development programs preferred • Experience developing and executing integrated regulatory strategies for complex programs • Oncology and both small-molecule and biologic experience preferred where relevant to the portfolio • Proven ability to lead high-stakes FDA interactions, negotiate effectively, resolve ambiguous or precedent-setting issues, and communicate clear recommendations to senior leaders • Strong strategic and business acumen • Ability to balance patient, scientific, regulatory, operational, and commercial considerations and make sound decisions under uncertainty • Documented success leading cross-functional teams, influencing without authority, and building alignment across global and U.S. stakeholders • Demonstrated people leadership, including recruitment, coaching, performance management, organizational development, and cultivation of future regulatory leaders • Excellent written and verbal communication skills • Strong judgment, integrity, collaboration, negotiation, conflict-resolution, and prioritization skills • Experience with Microsoft Office suite • Veeva regulatory publishing • PowerPoint presentation authoring and presentation • Business travel availability of 10–20% as required

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits • Equal opportunity employer and reasonable accommodation support