Senior Director, Regulatory Affairs

Position Overview

Adaptive is searching for a Senior Director, Regulatory Affairs to function as a key leader within our Measurable Residual Disease (MRD) business responsible for proactively developing, leading, and driving the execution of the global regulatory strategy for Adaptive’s diagnostics business.  This includes, but is not limited to, leading the development of timely regulatory plans for Adaptive’s diagnostic products, advising on product development and commercialization initiatives, and maintaining accountability for global regulatory compliance across the organization.

Reporting directly to the Chief Commercial Officer of our MRD Business Unit, you will manage a team of direct reports and also work collaboratively with Commercial, R&D, Operations, Quality Assurance, and Legal leadership to accomplish Adaptive’s regulatory and corporate objectives. 

Leaders at Adaptive demonstrate behaviors consistent with Adaptive’s Core Values and Leadership Principles. Critical functions of your role include helping establish individual team member goals, aligning those individual goals with broader team objectives, and ensuring those objectives drive the achievement of company goals. Providing thoughtful coaching and consistent feedback to your team members will drive performance excellence and accountability, as well as support your team members’ growth and development. Leaders at Adaptive create an environment of belonging, respect, and open and honest communication every day.  

Key Responsibilities and Essential Functions

• Provide management and leadership to the Regulatory Affairs team in the development and implementation of regulatory strategies and processes
• Lead the planning and preparation for meetings with regulatory agencies, and represent Adaptive during meetings and negotiations with regulatory agencies
• Monitor, interpret and communicate any emerging regulations, global regulatory trends, and guidelines.  Assess their impact on Adaptive’s products and operations and bring forward findings and recommendations.
• Monitor competitors’ regulatory activities and changes to anticipate potential impacts on the Adaptive’s products and regulatory strategies.
• Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies, within applicable regulations and guidelines; ultimate responsibility for reviewing and approving relevant regulatory filing documentation
• Assume responsibility for regulatory component of IVDR compliance
• Provide counsel, training and interpretation of FDA and global regulatory requirements to all company personnel
• Provide regulatory oversight and guidance for compliant product promotion
• Serve as primary contact responsible for communications with the U.S. and global regulatory agencies.  Develop and maintain external relationships with relevant opinion leaders and regulatory officials
• Identify and assess regulatory risks related to planned clinical development activities; develop mitigation strategies and work closely with cross-functional teams to ensure risk assessments are integrated into product development and lifecycle management processes.
• Leverage knowledge of pharma drug development trends and evolving regulatory agency viewpoints on MRD in hematology to inform a forward-looking regulatory strategy that supports expansion of Adaptive’s MRD pharma business.
• Work cross-functionally with collaborators to support delivery of pharma partner regulatory requirements, including clinical trials IDEs and other relevant applications.
• Understand and translate regulatory intelligence, scientific, operational and business knowledge into effective strategy and implementation plans for key product development initiatives.
• Direct the development of systems, practices and processes to ensure effective ongoing review of product design or other operational and manufacturing changes.
• Partner with Quality to oversee post-market regulatory surveillance, and reporting, and regulatory audits to ensure compliance and optimal market access.
• Set and maintain regulatory policies and standard operating procedures (SOPs) to ensure compliance with applicable regulations worldwide.  Train cross functional teams accordingly.
• Provide leadership, direction and oversight to manage regulatory policy deviation events that may impact compliance status or create business risk.
• Serve as a member of the Quality Management Review team.

Position Requirements (Education, Experience, Other)

Requirements

• BA/BS undergraduate degree in life sciences. MS, PhD or other relevant advanced degree strongly preferred.
• 17+ years (14+ with MS, or 10+ with PhD) of progressive management experience in global regulatory affairs in a diagnostic, medical device or life sciences technology-driven company.
• Experience with diagnostic product regulatory submissions in relevant therapeutic areas (hematology, oncology, immunology); experience with next-generation sequencing or similar high complexity diagnostic products highly preferred.
• Experience in strategic planning and collaboration with executives, key operational groups and external partners.
• Expertise with all phases of the product development lifecycle, including feasibility, design, development, transfer, verification and validation activities necessary for research and diagnostic product commercialization.
• Extensive experience in ISO, CLIA, CAP, CLEP, GxP and other Regulatory compliance requirements.
• Proven hands-on experience in submission and approval of US regulatory filings and reporting including US PMA, de novo, IDE, and 510(k) filings; cDx experience highly preferred
• Relationships with and ability to personally engage current CDRH leadership highly preferred
• Knowledge of and direct experience with market entry strategies, regulatory pathways and approval process in other key countries/regions globally (e.g., Canada, major European markets, Japan, Australia, China)
• History of successful direct interactions and negotiations with regulatory agencies.
• Experience directly implementing or partnering with Quality leadership to implement and managing quality/compliance systems and ensuring inspection readiness in alignment with requirements of global regulatory authorities.

Working Conditions

• Work is performed in an office environment.
• Occasional travel required for meetings with team, regulatory agencies, and customers

#LI-Remote

Compensation

Salary Range

• $204,300 - $306,500

Other compensation elements include:

• equity grant
• bonus eligible