[Hiring] Senior Principal, Regulatory Strategy @Lumanity

Role Description

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.

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

Requirements

• 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
• 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
• 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
• 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
• 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

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 and much more