Director/Senior Director, Regulatory Counsel

The posting, as Flagship Pioneering, Inc. wrote it

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 governme

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n 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.