Director/Senior Director, Regulatory Counsel

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.

POSITION SUMMARY

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.

RESPONSIBILITIES

The Regulatory Counsel shall be responsible for the following duties and 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.

EDUCATION REQUIREMENTS

The following educational qualifications are required for the Regulatory Counsel position:

• 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.

EXPERIENCE REQUIREMENTS

The following professional experience qualifications are required or preferred for the Regulatory Counsel position:

• 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 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.

• Experience working in a law firm or in-house legal department, with a demonstrated ability to manage outside counsel efficiently.

SKILLS AND COMPETENCIES

The Regulatory Counsel shall possess or demonstrate the following skills and competencies:

• 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.

WORK STRUCTURE AND LOCATION

This position follows an in-person work structure at Flagship Pioneering's Headquarters located in Cambridge, Massachusetts.

Specific scheduling expectations for in-person attendance will be coordinated with senior management and may be adjusted from time to time based on business needs and team requirements.

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

Flagship Pioneering and its ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.

All employment decisions, including but not limited to hiring, promotion, compensation, benefits, transfers, training, discipline, and termination, shall be made without regard to any protected characteristic as defined by applicable federal, state, and local law. This commitment applies to all terms and conditions of employment and to all aspects of the employment relationship.

INCLUSIVE HIRING STATEMENT

At Flagship, we recognize there is no perfect candidate. If you have some of the experience listed above but not all, please apply anyway. Experience comes in many forms, skills are transferable, and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.

RECRUITMENT AND STAFFING AGENCY NOTICE

Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates directly. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless such agency has been contacted directly by Flagship Pioneering's internal Talent Acquisition team.

Any resume submitted by a recruitment or staffing agency in the absence of a signed agreement between the agency and FSP will automatically become the property of FSP. FSP will not owe any referral fees, placement fees, or other compensation with respect to any such unsolicited submission.

By submitting an unsolicited resume to FSP or any of its employees, the submitting agency acknowledges and agrees to the terms set forth in this notice.

#LI-NM1

Privacy Notice for Applicants: When you apply for a role at Flagship Pioneering or one of its portfolio companies, we collect and use personal information you provide (such as your name, contact details, work history, and application materials) to evaluate your application, communicate with you, and comply with legal obligations. Your application data is processed through Greenhouse, our applicant tracking system, and may also be reviewed using AI-assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information. If you are located in the EU or UK, we process your data under GDPR and you have rights to access, rectify, and erase your data. To exercise your rights or for questions, contact privacy@flagshippioneering.com.

The salary range for this role is $172,000 - $280,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Flagship Pioneering currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Flagship Pioneering's good faith estimate as of the date of publication and may be modified in the future.

Privacy Notice for Applicants: When you apply for a role at Flagship Pioneering or one of its portfolio companies, we collect and use personal information you provide (such as your name, contact details, work history, and application materials) to evaluate your application, communicate with you, and comply with legal obligations. Your application data is processed through Greenhouse, our applicant tracking system, and may also be reviewed using AI-assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information. If you are located in the EU or UK, we process your data under GDPR and you have rights to access, rectify, and erase your data. To exercise your rights or for questions, contact privacy@flagshippioneering.com.