Executive Director/VP Regulatory Affairs
Biofidelity’s mission is to improve and extend cancer patients’ lives by enabling better targeting of therapies, early detection of treatment resistance, and routine monitoring of treatment response. Our unique technology is designed to allow rapid, broad adoption of our assays in testing labs around the world, enabling a step change in patient care.
At Biofidelity we are proud to have built a culture of humanity, openness and high expectations. We work towards well-defined goals, with a strong belief that we can bring real benefits to patients. Our people are keen to take responsibility for their work and share both their successes and challenges.
Biofidelity is looking for a dynamic, efficient and results-oriented Executive Director/VP Regulatory Affairs to lead the planning, development and execution of our global regulatory affairs strategy for our first diagnostic product and create fit for purpose regulatory function within the company. This position reports to the Chief Medical Officer, and is remote based.
Design, develop and deliver global regulatory affairs strategy to gain product approvals worldwide and bring products to market with optimum compliance
Drive, develop and implement the US and international regulatory plans and filings for our diagnostic products
Represent Biofidelity before regulatory authorities
Provide oversight and leadership of all regulatory submissions to ensure complete and timely submissions to authorities
Maintain an up-to-date knowledge of regulatory policies and procedures, and interpret trends that directly affect business decisions
Provide expert regulatory advice, interpretation and guidance throughout all stages of product development
Broaden the knowledge of regulatory aspects within R&D, clinical and commercial teams to help identify the optimal path to bring products to market
Work closely with Quality Management to ensure Biofidelity’s quality system is efficient and compliant with regulatory requirements
Support corporate compliance review for externally facing communications, working closely with medical affairs, marketing and corporate communication activities, including review of publications as required.
Knowledge, Skills, And Abilities:
Proven strategic and leadership capabilities of building global Regulatory Affairs infrastructure and building teams
Experience with diagnostic development, oncology and hematology clinical biomarker development, and Next Generation Sequencing platforms
Good understanding of the multiple routes to approval of a diagnostic product, including Companion Diagnostics
Solid knowledge of overall compliance, including Quality Assurance and Quality Management Systems
Excellent verbal and written communication skills with an ability to communicate across a variety of audiences including team members, cross-functional project teams, leaders, and senior management and external agencies
Excellent cross-functional leadership and project management organizational skills, with strong attention to detail
Strategic thinker with ability to focus, execute and deliver on specific tactical needs and operational sides of the role as we build the team
Cross-cultural awareness, ability to thrive in a small, dynamic and rapidly growing company environment
Willingness to travel as required
Requisite Education and Experience/Minimum Qualifications:
M.S. degree or higher in a life science field is minimum. Ph.D. or equivalent is highly desired
RAC accreditation is desirable, and IVD and CDx experience strongly preferred
5+ years of leadership experience in regulatory affairs function working on FDA regulatory submissions
Experience and understanding of ex-US regulatory diagnostics registrations and approvals. PMA submission experience a plus
Demonstrated leadership in engaging in direct negotiations with regulatory bodies in resolving issues with submissions