The Opportunity
PHALANX8 is building a differentiated Regulatory Strategy and FDA Risk advisory capability for life sciences organizations operating under accelerating regulatory scrutiny. The Managing Director, Regulatory Strategy & FDA Risk will shape and lead this capability, advising executive teams on how to anticipate regulatory risk, make defensible strategic choices, and navigate critical FDA inflection points across the product lifecycle.
This role sits at the intersection of regulatory judgment, enterprise risk, and executive decision-making. It offers the opportunity to define how regulatory strategy is practiced at scale, influence high-impact development and approval decisions, and build a market-recognized platform within a growing life sciences consulting firm.
Responsibilities
Practice Strategy and Capability Development
Define and execute the strategic vision for Regulatory Strategy and FDA Risk services. Build scalable offerings spanning global regulatory strategy, FDA risk assessment and mitigation, regulatory intelligence and horizon scanning, and regulatory operating model design. Develop repeatable methodologies, tools, and frameworks that support consistent, high-quality delivery across engagements.
Executive Client Advisory
Serve as senior advisor on complex regulatory strategy and FDA risk engagements. Guide clients through regulatory pathway selection, portfolio-level regulatory risk, development and approval strategy, and major regulatory milestones including INDs, NDAs/BLAs, PAIs, and post-approval changes. Support executive decision-making during high-impact regulatory events and periods of heightened scrutiny.
Business Development and Growth
Own revenue and growth targets for the Regulatory Strategy and FDA Risk portfolio. Originate, shape, and close new consulting opportunities. Build trusted relationships with C-suite leaders and senior regulatory, quality, and R&D executives. Partner with other practice leaders to deliver integrated, cross-functional solutions.
People and Leadership
Recruit, develop, and retain high-performing regulatory consultants. Build leadership depth and succession across Directors, Principals, and senior staff. Provide mentorship and coaching that reinforces sound regulatory judgment and consulting discipline.
Thought Leadership and Market Presence
Represent the firm through publications, conference participation, and industry forums. Monitor FDA policy, guidance, and enforcement trends. Translate emerging regulatory developments into new service offerings and perspectives that strengthen the firm’s market position.
You
You are a senior regulatory leader with deep experience shaping regulatory strategy and managing FDA risk in complex, high-stakes environments. You bring a strong understanding of global regulatory frameworks and the drug and/or device development lifecycle, combined with the ability to advise executive teams with clarity and authority.
You have demonstrated leadership in regulatory affairs or regulatory consulting, including direct interaction with the FDA and other health authorities. You are commercially minded, comfortable owning revenue targets, and effective at building long-term executive relationships. You exercise sound judgment, communicate with precision, and can influence decisions at the C-suite and board levels.
Compensation and Benefits
PHALANX8 offers a competitive executive compensation package aligned to role scope and experience, including base compensation and performance-based incentives tied to practice growth and client outcomes. Benefits include comprehensive health coverage, retirement plans, and flexibility consistent with a senior leadership role. The firm supports professional development, thought leadership, and long-term career growth within a collaborative, high-standard environment.
Your Leadership, Our Platform
PHALANX8 is building senior capability across regulatory strategy, quality, and compliance. The platform is designed for leaders who want to shape scalable offerings, advise executives in high-stakes moments, and build teams that deliver work with rigor and consistency.
If this role matches how you operate and what you want to build, apply now.
Equal Opportunity Employer
PHALANX8 is an Equal Opportunity Employer. We make employment decisions based on business needs, role requirements, and individual qualifications. We do not discriminate on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, or related conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, or any other status protected by applicable law.
PHALANX8 is committed to a workplace where respect and professionalism are expected, and where different perspectives strengthen how we think and deliver.
