Senior Principal, Regulatory Strategy

Overview/About Lumanity

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 Senior Principal, Regulatory Strategy is a senior strategic consultant who combines deep regulatory technical expertise with strong consulting and biopharma experience to deliver high-impact regulatory strategies for C-level and function-head client executives.

This role partners closely with the SVP & Practice Lead to execute Lumanity's Clinical & Regulatory practice strategy, while maintaining direct accountability for client delivery, business development, and the growth and mentorship of team members.

The Senior Principal serves as a trusted regulatory advisor, applying deep subject-matter expertise to shape clients' most critical development decisions, while actively building Lumanity's presence and revenue within their professional network and the broader life sciences ecosystem.

Essential Duties/Responsibilities

Strategic Advisory & Client Partnership

• Acts as a trusted advisor to pharmaceutical and biotech C-suite executives and function heads, providing expert regulatory guidance that shapes critical development and program-level and portfolio-focused decisions
• Provides expert regulatory guidance on complex development programs, including novel modalities (cell/gene therapy, biologics, advanced therapeutics)
• Collaborates with other Lumanity practices to deliver integrated solutions addressing interconnected approval and access challenges

Commercial Accountability & Growth

• Actively generates new business for Lumanity, meeting individual sales targets through engagement with professional networks and the broader life sciences ecosystem, including securing new business with net-new clients
• Leads pursuit strategies for complex regulatory engagements and supports broader practice BD efforts, including mentoring junior consultants on business development skills
• Develops multi-year account strategies for key relationships, identifying priority client needs and shaping demand across Lumanity's offerings to strengthen trust and secure repeat engagements

Delivery Excellence & Team Leadership

• Provides strategic oversight across engagements, serving as a senior escalation point to proactively manage risk and protect delivery quality and client trust, while ensuring consistency and quality in regulatory strategy outputs and balancing profitability with client value
• Guides the development and mentorship of Lumanity team members as they grow through their consulting careers, carrying direct reports where team structure and need require it
• Champions collaboration and knowledge sharing across markets, supporting reuse of regulatory frameworks and best practices

Market Presence & External Influence

• Represents Lumanity at industry forums and regulatory conferences, building external credibility and market presence
• Monitors the regulatory competitive landscape and shares insights that inform practice positioning and service evolution

Practice Contribution & Innovation

• Partners with the SVP to help translate regulatory landscape changes (AI/digital submissions, global harmonization, policy evolution) into practice growth opportunities, with real flexibility to build out capabilities in the areas where personal interests and expertise are strongest
• Develops regulatory points of view and thought leadership that contribute to Lumanity's positioning as an authoritative voice in regulatory strategy consulting
• Contributes to the evolution of consulting methodologies and the development of new service offerings to address emerging regulatory challenges and client needs

Qualifications

• Minimum 15+ years progressive regulatory experience with demonstrated success in both consulting environments and in-house biopharma regulatory roles
• Direct experience leading regulatory strategies for development programs across multiple stages and therapeutic areas and/or product types
• Demonstrated success contributing to or managing regulatory workstreams, projects, and teams
• Proven ability to serve as a trusted advisor to pharmaceutical/biotech function heads and C-suite executives
• Strong expertise across pre-IND through post-market/access regulatory activities, including designations, accelerated approval pathways, and complex regulatory strategies
• 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 working knowledge of global regulatory harmonization
• Deep regulatory expertise in 1+ major therapeutic area (oncology, CNS, rare disease, immunology, etc.), with working knowledge and comfort working across others
• Experience across multiple product types, including small molecules, biologics, cell/gene therapies, and/or combination products
• PhD, MPH, or MS in life sciences, regulatory affairs, or related field; MBA, RAC certification, or equivalent business/regulatory qualifications preferred
• Demonstrated ability to generate business and meet individual sales/revenue targets, with experience managing engagement-level budgets
• Experience contributing to the development of new service offerings or capabilities within regulatory consulting
• Active engagement in regulatory thought leadership, speaking engagements, and/or recognition as a subject-matter expert within one's professional network

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:

• 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

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