Vice President, Regulatory Strategy

🔥 21 hours ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

👔 Vice President

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 10%

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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Lumanity

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2020

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Lumanity is focused on improving the candidate experience through modern digital solutions. The company's initiatives include streamlining the application process and utilizing anonymous data to enhance user interaction on their platform. They emphasize privacy and compliance in their operations, ensuring that candidate data is handled with care and transparency.

📋 Description

• Act as a trusted strategic partner to pharmaceutical and biotech C-suite executives and functional heads • Influence enterprise-wide regulatory strategies across multiple development programs and corporate initiatives • Provide authoritative regulatory guidance on complex, multi-indication development programs, including novel modalities • Partner with other Lumanity practices to deliver integrated regulatory, clinical, and quality solutions • Translate regulatory landscape changes into practice growth opportunities and competitive differentiation • Develop regulatory points of view that influence industry standards and policy dialogue • Evolve consulting methodologies and develop new service offerings • Support the Clinical & Regulatory P&L and achieve annual revenue targets while maintaining profitability margins • Lead pursuit strategies for complex, high-value regulatory engagements and mentor business development capability • Set delivery quality standards across the regulatory team • Shape regulatory talent strategy through succession planning and mentorship • Champion collaboration and knowledge sharing across markets • Represent Lumanity at senior industry forums and regulatory conferences • Monitor the regulatory competitive landscape and translate insights into practice positioning and service evolution

🎯 Requirements

• 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

🏖️ Benefits

• 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