Senior Principal, Regulatory Strategy

Lumanity•Remote,

6d•Remote

About The Position

Lumanity is a global strategic partner focused on improving health outcomes by accelerating and optimizing access to life-changing medicines. The Senior Principal, Regulatory Strategy is a senior strategic consultant combining deep regulatory expertise with consulting and biopharma experience to deliver regulatory strategies for senior client executives. The role partners closely with the SVP & Practice Lead to execute the Clinical & Regulatory practice strategy, while holding direct accountability for client delivery, business development, and team growth and mentorship. The Senior Principal advises clients on critical development decisions and builds Lumanity’s presence and revenue across their professional network and the life sciences ecosystem. The position includes strategic client advising, business development and account growth, engagement oversight, team mentorship, external representation, and contributions to practice strategy, thought leadership, consulting methods, and new service offerings. Areas of evolving practice opportunity include AI and digital submissions, global harmonization, and policy evolution.

Requirements

At least 15 years of progressive regulatory experience, including demonstrated success in consulting environments and in-house biopharma regulatory roles.
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.
Ability to serve as a trusted advisor to pharmaceutical and 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, including EMA, Health Canada, and PMDA, and working knowledge of global regulatory harmonization.
Deep regulatory expertise in at least one major therapeutic area, such as oncology, CNS, rare disease, or immunology, and comfort working across other areas.
Experience across multiple product types, including small molecules, biologics, cell and gene therapies, and/or combination products.
PhD, MPH, or MS in life sciences, regulatory affairs, or a related field.
Demonstrated ability to generate business and meet individual sales or 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 or speaking engagements, and/or recognition as a subject-matter expert within a professional network.

Nice To Haves

MBA, RAC certification, or equivalent business/regulatory qualifications preferred.

Responsibilities

Advise pharmaceutical and biotech C-suite executives and function heads on regulatory matters affecting development, program, and portfolio decisions.
Provide regulatory guidance on complex development programs, including novel modalities such as cell and gene therapies, biologics, and advanced therapeutics.
Collaborate with other Lumanity practices to develop integrated solutions for approval and access challenges.
Generate new business, meet individual sales targets, and secure business with new clients through professional networks and the broader life sciences ecosystem.
Lead pursuit strategies for complex regulatory engagements and support practice business development, including mentoring junior consultants in business development.
Develop multi-year account strategies for key relationships, identify client needs, and shape demand across Lumanity offerings.
Provide strategic oversight across engagements, manage risks, protect delivery quality and client trust, and balance profitability with client value.
Ensure consistency and quality in regulatory strategy outputs and serve as a senior escalation point.
Guide and mentor team members, with direct reports where required by team structure and need.
Promote collaboration and knowledge sharing across markets and support reuse of regulatory frameworks and best practices.
Represent Lumanity at industry forums and regulatory conferences.
Monitor the regulatory competitive landscape and share insights that inform practice positioning and service evolution.
Partner with the SVP to translate regulatory changes into practice growth opportunities.
Develop regulatory points of view and thought leadership.
Contribute to consulting methodologies and develop new service offerings addressing emerging regulatory challenges and client needs.