Director/Senior Director, Regulatory Counsel

Flagship Pioneering, Inc.•Cambridge, MA

6d•$172,000 - $280,500•Onsite

About The Position

Flagship Pioneering is a scientific innovation engine that invents and builds companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps in human health, sustainability, and beyond. What sets Flagship apart is our ability to advance biotechnology by uniting life science innovation, company creation, and capital investment under one roof in a way that is largely without precedent. Our team of scientists, entrepreneurial leaders, and professional capital managers are each aligned around an institutionalized process that enables us to innovate and create breakthroughs for the benefit of people and planet. Many of the companies Flagship has founded have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture. Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been named four times to Fast Company’s annual list of the World’s Most Innovative Companies. This is an outstanding career opportunity for a highly motivated Regulatory Counsel to join the Legal team at Flagship Pioneering. The Regulatory Counsel will lead regulatory efforts tied to Flagship's government contracting obligations and will also advise more broadly on GxP matters supporting Pioneering Medicines' growth, as well as Consumer, Digital Health, and Medical Device matters. This is a rare cross-platform mandate: rather than owning a single therapeutic area, the Regulatory Counsel will shape regulatory strategy across Flagship's entire portfolio of emerging technologies. The Regulatory Counsel will also support Flagship's international expansion markets, with the goal of accelerating regulatory decision-making. This position carries high visibility across the organization and requires a proactive, positive, and professional approach at all times.

Requirements

Law Degree: The candidate must hold a Juris Doctor (J.D.) degree from an accredited law school.
Bar Admission: The candidate must be admitted to the bar in at least one (1) U.S. state and must be in good standing at the time of hire and throughout the duration of employment.
A minimum of six (6) to ten (10) years of professional experience in regulatory law, with substantial experience in government contracting regulation (e.g., FAR/DFARS) and life sciences regulatory matters (e.g., GxP, FDA).
Experience working in a law firm or in-house legal department, with a demonstrated ability to manage outside counsel efficiently.
Deep subject-matter expertise in regulatory frameworks applicable to government contracting and/or life sciences.
Ability to translate complex regulatory requirements into clear, actionable guidance for business and scientific teams.
Strong judgment and the ability to make and support timely regulatory decisions in a fast-paced environment.
Excellent negotiation, drafting, and analytical skills.
Ability to manage outside counsel relationships efficiently, including scoping engagements and transitioning work in-house over time.
High level of responsiveness and exceptional interpersonal and communication skills across the Flagship ecosystem.
Demonstrated willingness and enthusiasm to learn, evaluate, and apply state-of-the-art AI legal tools to improve the quality, speed, and efficiency of day-to-day legal work.

Nice To Haves

Experience advising on Consumer/Digital Health and/or medical device regulatory matters is strongly preferred.
Experience with international regulatory strategy, particularly in China, Australia, or other priority ex-U.S. markets, is a plus.

Responsibilities

Lead regulatory efforts tied to Flagship's government contracting obligations, partnering with Flagship’s Compliance group.
Embed practical, business-oriented regulatory guidance supporting GxP compliance and Pioneering Medicines' growth initiatives.
Advise Consumer and Digital Health initiatives and provide regulatory guidance on medical device matters.
Support international expansion efforts, including clinical-development regulatory strategies in various priority markets.
Accelerate regulatory decision-making across the organization.
Monitor regulatory developments relevant to Flagship's government contracting, GxP, Consumer/Digital Health, and medical device activities, and advise leadership on emerging risks and requirements.
Partner with the Compliance Manager to build scalable, in-house regulatory and compliance capability across the Flagship ecosystem.