Vice President, Regulatory Strategy

Lumanity

Greater London

On-site

GBP 180,000 - 240,000

Full time

14 days+

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Benefits offered by this job

Competitive salary plus bonus

Medical, dental, and vision insurance

401(k) plan with employer match

Flexible PTO

Flexible spending accounts

Health savings account

Employee Assistance Program

Disability coverage

Job summary

Lumanity is seeking a Vice President, Regulatory Strategy in London/remote-eligible capacity. You will lead enterprise regulatory strategy for global programs, influence C-suite decisions, and drive growth across oncology, CNS, and other modalities.

You will shape policy dialogue, mentor leaders, and partner with other practices to deliver integrated regulatory support while maintaining profitability and client value.

Qualifications

Minimum 20+ years progressive regulatory experience in consulting and in-house leadership roles.
Direct experience leading regulatory strategies for development programs across stages and therapeutic areas.
Proven ability to advise pharmaceutical/biotech executives at VP or C-Suite level.
Deep expertise across pre-IND to post-market activities, including designations and accelerated pathways.
Experience leading Pre-IND meetings, Type C meetings, and EOP2 discussions.
International regulatory experience across EMA, Health Canada, PMDA and global harmonization.
Experience with multiple product types including small molecules, biologics, and cell/gene therapies.

Responsibilities

Act as trusted strategic partner to C-suite executives influencing enterprise-wide regulatory strategies.
Provide authoritative regulatory guidance on complex development programs including novel modalities.
Partner with other practices to deliver integrated regulatory, clinical, and quality solutions.
Translate regulatory landscape changes into growth opportunities and competitive differentiation.
Develop regulatory viewpoints that influence industry standards and policy dialogue.
Evolve methodologies and services to address emerging regulatory challenges and client needs.
Support revenue targets and profitability in collaboration with senior leadership.
Lead regulatory talent strategy including succession planning and mentorship.
Represent Lumanity at regulatory forums and industry conferences to build credibility.

Skills

Regulatory leadership

Executive advisory

Global regulatory expertise

Pharma regulatory experience

Pre-IND meetings

Cross-functional collaboration

Team management

Regulatory policy

Education

PhD, MPH, or MS in life sciences

MBA, RAC or equivalent

Job description

Overview / About us

Lumanity is dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. As a global strategic partner that brings together strategy, evidence, engagement, and technology, we were designed to engineer breakthrough value to tackle our clients’ toughest challenges by revolutionizing how value is generated, demonstrated, and communicated.

Responsibilities / Position overview

The Vice President, Regulatory Strategy is a senior enterprise leader who combines deep regulatory technical expertise with proven consulting and biopharma experience to drive practice growth and deliver transformational regulatory strategies for VP and C‑suite client executives. This role partners with the SVP & Practice Lead to shape the future direction of Lumanity’s Clinical & Regulatory practice while maintaining direct accountability for revenue growth, client relationships, and team development across global markets.

The VP serves as a senior regulatory authority, translating regulatory landscape evolution into practice opportunities, building unique competitive capabilities, and positioning the firm as the go-to regulatory strategy authority for complex, high-stakes pharmaceutical development programs.

Essential Duties/Responsibilities

Strategic Leadership & Client Partnership

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

Practice Strategy & Innovation

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

Commercial Accountability & Growth

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

Delivery Excellence & Team Leadership

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

Market Presence & External Influence

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

Qualifications

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

We offer our employees a comprehensive benefits package that focuses on what matters to you - health and well-being, personal finances, professional development, and a healthy work/life balance: