Vice President, Regulatory Affairs

🕒 Abril 2

🏄 California – Remoto

🏄 California – Remote

💵 $259.000 - $394.000 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

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Vera Therapeutics, Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

Vera Therapeutics, Inc. é uma empresa de biotecnologia em estágio clínico focada no desenvolvimento de tratamentos para doenças renais imunológicas que melhorem a vida dos pacientes. A empresa está avançando com o Atacicept através do desenvolvimento clínico para nefropatia por IgA (IgAN), conduzindo testes de Fase 2b e Fase 3, e perseguindo programas em nefrite lúpica e outras condições imunológicas. Com sede em Brisbane, CA, a Vera enfatiza o desenvolvimento de medicamentos orientado pela ciência, o engajamento com os pacientes e a sustentabilidade.

Descrição

• Develop and lead integrated global regulatory strategies (US, EU, and key ex‑US markets) for all pipeline programs, aligning with overall corporate and clinical development goals. • Serve as a primary regulatory strategist providing clear assessments of regulatory options, risks, and timelines to inform portfolio and investment decisions. • Oversee planning, authoring, review, and submission of regulatory dossiers including pre‑IND/IMPD packages, INDs/CTAs, IBs, pediatric plans, orphan/expedited program requests, DSURs/PSURs, NDAs/BLAs/MAAs, and post‑approval supplements/variations. • Lead or directly oversee global health authority interactions (e.g., FDA, EMA, PMDA and key national agencies), including scientific advice/protocol assistance, Type B/C meetings, pre-submission and advisory committee preparations; ensure high‑quality briefing packages and robust meeting follow‑up. • Partner closely with cross-functional teams to ensure clinical trial designs, endpoints, and statistical plans are aligned with regulatory expectations and support future registration. • Oversee global CMC regulatory strategies, including module 3/quality sections, comparability plans, and lifecycle management; ensure alignment with GxP and ICH requirements. • Ensure timely, accurate maintenance of all active INDs/CTAs and marketing authorizations, including safety reports, annual reports, labeling updates, and other commitments. • Build, lead, and mentor a high‑performing regulatory team effectively leveraging external consultants, CROs, and vendors for eCTD publishing and ex‑US submissions. • Establish and continuously improve phase‑appropriate regulatory processes, standards, and governance (e.g., submission planning, HA interaction tracking, labeling governance) suitable for a lean organization. • Stay current on evolving global regulatory requirements, guidance, and precedent, and proactively incorporate learnings into program strategies and company policies. • Support business development activities by contributing regulatory due diligence, risk/benefit assessments, and integration planning for potential partnerships, in‑licensing, and acquisitions. • Represent Regulatory Affairs on cross‑functional governance bodies and, as needed, with partners, and external stakeholders.

🎯 Requisitos

• Advanced degree in life sciences or related discipline (e.g., PhD, PharmD, MD, or MS); equivalent experience may be considered. • 15+ years of increasing responsibility in biopharmaceutical regulatory affairs, including substantial experience in small or mid‑size biotech environments. • Proven track record of leading major global submissions (IND/CTA and NDA/BLA/MAA or equivalent) through acceptance and, ideally, approval. • Demonstrated experience interacting directly with FDA, EMA and other global health authorities, including leading meetings and negotiations on complex issues. • Strong understanding of global regulatory frameworks (ICH, FDA, EMA and other regional requirements) across early development, registration, and post‑approval lifecycle management. • Experience overseeing or partnering with CMC, regulatory operations/electronic submissions (eCTD), and safety/periodic reporting activities. • Demonstrated ability to build, lead, and develop teams, and to work effectively as both a hands‑on individual contributor and strategic leader in a lean, fast‑paced biotech setting. • Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly to both technical and non‑technical audiences, including senior leadership and external partners. • High degree of integrity, sound judgment, and a pragmatic, solutions‑oriented mindset with strong organizational and project management skills.

🏖️ Benefícios

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options