Vice President, Regulatory Affairs

🕒 vor 2 Monaten

🏄 California – Remote

🏄 California – Remote

💵 $259.000 - $394.000 / Jahr

⏰ Vollzeit

🔴 Experte

🚔 Compliance

Jetzt Bewerben

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Vera Therapeutics, Inc.

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201 - 500 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

Biotechnology • Pharmaceuticals

Vera Therapeutics, Inc. ist ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das sich auf die Entwicklung von Behandlungen für immunologische Nierenerkrankungen konzentriert, um das Leben der Patienten zu verbessern. Das Unternehmen treibt die klinische Entwicklung von Atacicept zur Behandlung der IgA-Nephropathie (IgAN) voran und führt Studien der Phase 2b und Phase 3 durch. Darüber hinaus verfolgt es Programme zur Behandlung von Lupusnephritis und anderen immunologischen Erkrankungen. Mit Hauptsitz in Brisbane, Kalifornien, legt Vera besonderen Wert auf wissenschaftsorientierte Arzneimittelentwicklung, Patientenengagement und Nachhaltigkeit.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

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