Regulatory Affairs, Associate Director
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
Position summary:
Strong regulatory partner to the Multi-Cancer Early Development (MCED) Product Development and Business Teams. Leads organization in the development of submissions for product registrations, progress reports, supplements, amendments, and/or periodic experience reports etc. Provides strategic product direction to teams and negotiates with regulatory agencies to expedite approval of IVD product registrations. Monitors and communicates regulatory strategy and changes in regulatory requirements to project teams and leadership. May manage, lead and provide direction to Regulatory Staff and when required participate in Senior Management meetings as a delegate. Develops and drives a work culture committed to compliance, quality and customer focus.
Your tasks and responsibilities will include:
- Develop proactive approaches for regulatory activities to meet business requirements.
- Manage submission activities for a variety of device regulatory submissions and approvals including US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations, device listings.
- May serve as a key member of the Regulatory Leadership team providing insights, solutions and direction on general business and product portfolio matters.
- Provides regulatory support to new and currently marketed products, e.g., labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
- Reviews, interprets, and reports to Regulatory leadership on product specific regulatory issues that may have material impact on the business or the customer.
- Works with Regulatory Affairs leadership to develop strategic and tactical responses to influence a reasonable regulatory environment.
- Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
- Leads the identification of regulatory risk areas and develops alternative courses of action.
- Assess impact of new regulations and work with cross-functional partners to implement appropriate changes.
- Represents GRAIL during communications and meetings with Health Authorities and interfaces with regulatory authorities on regulatory and technical matters, as appropriate.
- Ensures compliance with regulations and laws pertaining to the GRAIL business and provides mentorship and advice.
- Independently reviews and approves Regulatory Strategy Documents, Regulatory Plans, procedures, SOPs and other documentation with respect to commitments, regulations and filings
- Manages the development and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
- Provides regulatory support on project teams and serves as a functional lead on project teams
- Provides consultative and training support to the business unit and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues
- If required, responsible for managing indirect and direct reports which includes, but is not limited to, hiring/firing decisions, selection, performance feedback, discipline, pay decisions, and handling employee’s grievances/complaints.
- Performs other duties as required or assigned
Your qualifications and background will include:
- B.S./B.A. in a science or related life science field; advanced degree preferred.
- Regulatory Affairs Certification preferred.
- Minimum of 8 years’ experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries. Regulatory affairs experience is preferred. IVD device experience is preferred. Advanced degree counts toward years of experience.
- Experience with regulatory submissions for IDE, 510(k), PMA and CE Mark
- Experience with Microsoft based applications and general knowledge of PC functions necessary.
- Experience in diagnostics or biomarker development with emphasis on oncology a plus
- Advanced scientific degree a plus
- Pharma clinical/statistical/regulatory experience in oncology, immunology or related field a plus
- Track record of leadership, providing sound judgment/ideas and business partnering
- Demonstrated knowledge of regulations and procedures required for development of new medical devices, submission of applications to the FDA and OUS (outside US) health authorities for approval to market new medical devices.
- Demonstrated ability to effectively present information to senior management and to regulatory agencies with experience in the design and development of formal meetings and presentations to FDA for 510(k), IND, IDE, PMA, NDA/BLA level agency interactions, including pre-submission meetings and advisory committees.
- Strong interpersonal/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations
- Ability to interpret and respond to requests from regulatory agencies.
- Ability to work in a fast-paced/entrepreneurial team environment.
- Excellent oral and written communication skills.
- Strong organizational skills and attention to detail required.
- Ability to work in a cross-functional, highly interdependent team structure.
- Ability to drive and manage change with a positive approach.
- Passionate, focused, loves to have fun.
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.