Vice President, Regulatory Strategy

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Lumanity

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 2020

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Lumanity konzentriert sich darauf, die Kandidatenerfahrung durch moderne digitale Lösungen zu verbessern. Die Initiativen des Unternehmens umfassen die Optimierung des Bewerbungsprozesses und die Nutzung anonymer Daten, um die Benutzerinteraktion auf ihrer Plattform zu verbessern. Sie legen großen Wert auf Datenschutz und Compliance in ihren Abläufen und stellen sicher, dass Kandidatendaten mit Sorgfalt und Transparenz behandelt werden.

Beschreibung

• Acts as trusted strategic partner to pharmaceutical and biotech C-suite executives and other functional heads, influencing enterprise-wide regulatory strategies that extend across multiple development programs and corporate initiatives • Provides authoritative regulatory guidance on complex, multi-indication development programs, including novel modalities (cell/gene therapy, biologics, advanced therapeutics) • Partners with other Lumanity practices to deliver integrated solutions addressing interconnected regulatory, clinical, and quality challenges • Partners with SVP & Practice Lead to translate regulatory landscape changes (AI/digital submissions, global harmonization, policy evolution) into practice growth opportunities and competitive differentiation • Develops regulatory points of view that influence industry standards, shapes regulatory policy dialogue, and positions Lumanity as the authoritative voice in regulatory strategy consulting • Evolves consulting methodologies and develops new service offerings to address emerging regulatory challenges and client needs • Proactively supports the Clinical & Regulatory P&L, in collaboration with the SVP and Practice Lead, achieving annual revenue targets while maintaining target profitability margins • Dives personal and team BD performance, leading pursuit strategies for complex, high-value regulatory engagements while mentoring BD capability across the practice • Sets and reinforces delivery quality standards across regulatory team, ensuring consistency in regulatory strategy outputs while balancing profitability with client value • Shapes regulatory talent strategy through succession planning, mentorship of senior regulatory leaders, and development of next-generation regulatory capabilities • Champions collaboration and knowledge sharing across markets, accelerating reuse of regulatory frameworks and best practices • Represents Lumanity at senior industry forums and regulatory conferences building external credibility and market presence • Monitors regulatory competitive landscape and translates insights into practice positioning and service evolution

🎯 Anforderungen

• Minimum 20+ years progressive regulatory experience with demonstrated success in both consulting environments and in-house biopharma regulatory leadership roles • Direct experience leading regulatory strategies for development programs throughout all stages and across different therapeutic areas and product types • Demonstrated success managing regulatory practices or teams • Proven ability to serve as trusted advisor to pharmaceutical/biotech VP-level and C-suite executives • Deep expertise across pre-IND through post-market regulatory activities, including designations, accelerated approval pathways, and complex regulatory strategies • Extensive experience leading Pre-IND meetings, Type C meetings, EOP2 discussions, and other critical regulatory interactions • International regulatory experience across major markets (EMA, Health Canada, PMDA) with understanding of global regulatory harmonization • Deep regulatory expertise in 2+ major therapeutic areas (oncology, CNS, rare disease, immunology, etc.) • Experience across multiple product types including small molecules, biologics, cell/gene therapies, and combination products • PhD, MPH, or MS in life sciences, regulatory affairs, or related field • MBA, RAC certification, or equivalent business/regulatory qualifications • Proven track record achieving annual revenue targets with demonstrated budget management experience • Success in opening new markets or service lines within regulatory consulting • Published regulatory thought leadership, speaking engagements, and recognition as regulatory industry authority

🏖️ Vorteile

• Competitive salary plus bonus scheme • Medical, dental, and vision insurance options • 401(k) plan with employer match • Flexible PTO • Flexible spending accounts for health and dependent care • Health savings account option with employer contribution • Employee Assistance Program • Paid short-term and long-term disability coverage and much more