Director of Regulatory Affairs

BillionToOne is a next-generation molecular diagnostics company dedicated to developing powerful and accurate diagnostic tests that are accessible to all. Our innovative QCT molecular counting technology significantly enhances the resolution of disease detection using cell-free DNA by over a thousandfold. This groundbreaking technology is integral to our product offerings, including one of our flagship products, Unity Complete™, the only non-invasive prenatal screen capable of assessing fetal risk for both common recessive conditions and aneuploidies from a single maternal blood sample. Leveraging the same molecular counting technology, we've expanded our impact into oncology in 2023 with a pioneering liquid biopsy test, Northstar, that combines treatment selection with monitoring. To date, over 500,000 patients have benefited from our innovative and precise diagnostic tests, and our Annual Recurring Revenue (ARR) has grown from $0 to $125 million in the last ~4 years.

BillionToOne has successfully raised close to $400 million in funding, with a notable $130 million Series D round completed in June 2024, resulting in a company valuation of over $1 billion. This funding has come from prestigious global institutional investors, including Hummingbird, Adams Street Partners, Neuberger Berman, Baillie Gifford, and Premji Invest. BillionToOne has recently been recognized by Forbes as one of America's Best Startup Employers for 2024, highlighting the company's exceptional work environment and commitment to innovation.

Our team has grown significantly and we now proudly employ over 400 highly skilled individuals. Despite substantial growth, we have successfully maintained the unique culture that has defined BillionToOne from inception, continuing to cultivate a team that is not only diverse and passionate but also innovative. Headquartered in Menlo Park, California, with an additional facility in Union City, California, BillionToOne remains at the forefront of significant advances in molecular diagnostics, evidenced by the recent announcement of clinical outcomes data for its Unity Fetal Risk Screen and new advancements in cancer diagnostics. For more detailed information about BillionToOne and its groundbreaking work, please visit our website at www.billiontoone.com.

As the Director of Regulatory Affairs, you will be responsible for developing and implementing global strategies to secure and maintain market approval for BillionToOne product(s). In addition, you will help develop, maintain, and manage key Quality Management System (QMS) processes to ensure compliance with applicable regulations (CLIA, CAP, State DOHs, NYS, FDA, ISO, etc.). You will anticipate new or changing regulations and coordinate with internal stakeholders to develop strategies to address changes in products, operations, or quality system requirements. You will work closely with cross-functional stakeholders across BillionToOne (e.g. Lab Operations, R&D, Medical Affairs, Finance, Supply Chain, Sales) to manage Regulatory initiatives from initial requirements gathering to market approval. This role is a hybrid role (monthly onsite travel is required) and will report directly to the Vice President of QARA.

Responsibilities:

• Lead the Regulatory function in the development of global strategies in line with applicable regulations to achieve business objectives for development and marketed products. When necessary, seeks expert advice and technical support from functional stakeholders, supervisor, and outside regulatory counsel.
• Leads cross-functional stakeholders to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
• Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
• Leads preparation of global regulatory product strategies for assigned products. Proactively leads the regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plans to relevant stakeholders.
• Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
• Ensures alignment of global regulatory strategies with Sr. Management. Under minimal guidance of the supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management.  
• Proactively informs cross functional management of issues, labeling outcomes, approval or other risks and mitigations. Provides assessment of impact on global programs.
• Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advances the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects.
• Works directly with operating entities to provide regulatory analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Establish and actively manage expectations, provide training and mentoring to drive professional development for team members.
• Ability to travel between all corporate site locations.

Requirements:

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject).
• Relevant advanced degree is preferred. 
• Regulatory Affairs Certification (RAC) a plus.
• 5+ years of regulatory experience. Some portions should include relevant exposure to PMA regulatory work. 
• Proven 3-5 years in a leadership role with strong management skills.
• Experience interfacing with government regulatory agencies and Health Authority.
• Strong communication and verbal skills.
• Detail oriented with well-developed organizational and analytical skills. 
• Creative problem solving, flexibility, and good negotiation skills are a must.
• Ability to drive results to established timelines and on budget.
• Experience managing remote business activities.
• Must be comfortable and effective acting as a catalyst for change.
• Must be performance and results oriented and be able to develop, motivate and lead effective teams.
• Hard driver, high energy, positive attitude, works well under stress and with ambiguity.
• 25% travel required  

Benefits And Perks:

• Working with a team of ‘rockstars’ who bring out the best in everyone
• Open, transparent culture that includes weekly Town Hall meetings
• The ability to indirectly or directly change the lives of hundreds of thousands patients
• Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered at 80%
• Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
• Retirement savings program including a 4% Company match
• Free daily on-site lunches provided from top eateries
• Latest and greatest hardware (laptop, lab equipment, facilities)
• A variety of perks on campus (state of the art gym, restaurant)
• Free on-site EV charging (compatible with all EVs, including Tesla)

At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based experience and salary/equity options split that the candidate chooses) (2) generous equity options offering, on top of (3) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave etc.).

For this position, we offer a total compensation package of $350,000 per year, including a base pay range of $200,000-$225,000 per year.

BillionToOne is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.