Senior Principal, Regulatory Strategy

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver impactful regulatory strategies for C-level executives and function heads within client organizations.

• Collaborate with the SVP & Practice Lead to implement Lumanity's Clinical & Regulatory practice strategy.

• Take direct responsibility for client delivery, business development, team growth, and mentorship.

• Advise C-suite executives and function heads in the pharmaceutical and biotech sectors on critical decisions related to development, program-level, and portfolio management.

• Offer regulatory guidance on intricate development programs, including innovative modalities.

• Work alongside other Lumanity practices to provide comprehensive solutions that tackle approval and access challenges.

• Generate new business opportunities, achieve personal sales targets, and secure contracts with new clients.

• Lead strategies for pursuing complex regulatory engagements and support business development for the practice.

• Formulate multi-year account strategies for key relationships.

• Ensure strategic oversight across engagements while proactively managing risk and delivery quality.

• Mentor Lumanity team members and oversee direct reports as necessary.

• Promote collaboration and knowledge sharing across various markets.

• Represent Lumanity at industry forums and regulatory conferences.

• Keep track of the regulatory competitive landscape and share valuable insights.

• Transform changes in the regulatory landscape into opportunities for practice growth.

• Develop regulatory perspectives and contribute to thought leadership initiatives.

• Assist in refining consulting methodologies and the creation of new service offerings.

⛳️ Requirements

• A minimum of 15+ years of progressive experience in regulatory affairs.

• Proven success in both consulting environments and in-house regulatory roles within biopharma.

• Direct experience in leading regulatory strategies for development programs across various stages, therapeutic areas, and product types.

• Demonstrated success in contributing to or managing regulatory workstreams, projects, and teams.

• Established ability to act as a trusted advisor to executives and function heads in the pharmaceutical/biotech industry.

• Strong expertise in regulatory activities from pre-IND through post-market/access, including designations, accelerated approval pathways, and complex strategies.

• Experience in leading Pre-IND meetings, Type C meetings, EOP2 discussions, and other critical regulatory interactions.

• International regulatory experience in major markets (EMA, Health Canada, PMDA) with a solid understanding of global regulatory harmonization.

• In-depth regulatory expertise in at least one major therapeutic area (oncology, CNS, rare diseases, immunology, etc.).

• Familiarity and comfort working across various therapeutic areas.

• Experience with multiple product types, including small molecules, biologics, cell/gene therapies, and/or combination products.

• A PhD, MPH, or MS in life sciences, regulatory affairs, or a related field.

• Proven ability to generate business and achieve individual sales/revenue targets, with experience managing engagement-level budgets.

• Experience in contributing to the development of new service offerings or capabilities within regulatory consulting.

• Active involvement in regulatory thought leadership, speaking engagements, and recognition as a subject-matter expert within one’s professional network.

🏝️ Benefits

• Competitive salary with a bonus scheme.

• Options for medical, dental, and vision insurance.

• 401(k) plan with employer matching contributions.

• Flexible paid time off (PTO).

• Flexible spending accounts for health and dependent care.

• Health savings account option with employer contributions.

• Employee Assistance Program.

• Paid short-term and long-term disability coverage.

• Opportunities for professional development.

• Support for a healthy work/life balance.