Remote Director of Regulatory Affairs

Summary

Join BillionToOne, a next-generation molecular diagnostics company, as the Director of Regulatory Affairs. Develop and implement global strategies to secure market approval for products, manage Quality Management System processes, and lead cross-functional stakeholders. This hybrid role requires strong management skills, experience with government regulatory agencies, and ability to drive results.

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

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
• 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

Benefits

• 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)