Head of Regulatory Affairs

Job openings within E25Bio.

We are looking for the Head of Regulatory Affairs

Founded in 2018 and based out of The Engine, the company spun out of MIT using technology developed by Dr. Irene Bosch and Dr. Lee Gehrke, the Hermann von Helmholtz Professor of Health Sciences and Technology at MIT. E25Bio develops technology for rapid diagnosis of dangerous infectious diseases such as dengue, zika and utilizes a mobile application to track disease data information in real time. With investment from Khosla Ventures, E25Bio has since validated the test in clinical studies and looks to commercialize its product for point-of-care testing post FDA emergency use authorization.

Your Role

As the Head of Regulatory Affairs, your main role is to combine knowledge of scientific, regulatory and business issues to support e25bio’s diagnostic businesses in premarket activities with the U.S. Food and Drug Administration. The individual has Division level influence and is generally recognized as an expert resource both within e25bio and externally. The individual will provide strategic direction and technical guidance on regulatory requirements to a variety of e25bio’s development teams driving premarket strategies that lead to robust submissions and timely product approvals. 

The successful candidate will possess strong knowledge of FDA regulations and guidance documents pertaining to the regulation of in vitro diagnostics (IVD) and will be responsible for leveraging that expertise to support e25bio’s premarket objectives. 

Core job responsibilities include:

  • Prepare and submit applications to USA FDA
  • Develop e25bio’s strategy for regulatory compliance and application
  • Utilize technical regulatory skills to positioning strategies on complex premarket issues.
  • Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
  • Identify premarket trends and ensure consistent approach across e25bio’s businesses, where appropriate.
  • Monitor impact of changing regulations on submission strategies.
  • Provide recommendations on the organization and content of pre-submissions, submissions, interactive review responses, and deficiency responses.
  • Serve as regulatory subject matter expert throughout product lifecycle.
  • Manage projects involving multiple businesses and functional stakeholders.
  • Recruit develop and mentor regulatory professionals.

Key Success Factors

Leadership Develops, communicates, and builds consensus for premarket strategies that are in alignment with e25bio’s objectives, sound scientific principles, and regulator expectations · Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units · Builds strong relationships with business partners and stakeholders and leverages relationships to tactfully influence and gain their support to drive desired outcomes · Exercises judgment independently.

Planning Holistic, big picture thinker, who anticipates changes in regulation, regulator expectations, and/or business objectives and adapts approach as necessary to manage risks effectively and drive timely approval or clearance of e25bio’s IVD products · Creates immediate to long-range plans to carry out objectives established by senior management · Forecasts future departmental needs including human and material resources and capital expenditures.

Decision Making Assignments are expressed in the form of objectives · Work is performed without appreciable direction · Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management · Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

Collaboration Firm understanding of available regulatory and business resources and ability to integrate information from a number of sources to achieve business results, including breaking down boundaries to create alignment as necessary, in a complex, matrixed environment.

Education and Experience

  • Prior experience filing FDA submissions
  • Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields preferred.
  • M.S. in a technical area or M.B.A. preferred; a PhD in technical area or law is helpful but not required.
  • Certification is a plus (e.g., RAC from the Regulatory Affairs Professionals Society.)  
  • Preferable 15+ years of experience in a regulated industry required (e.g., medical devices, diagnostics, pharmaceuticals); experience in in-vitro diagnostics (IVD) strongly preferred.
  • 10+ years of experience in regulatory function preferred but may consider experience in quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Regulatory knowledge of:
    • FDA regulations, guidance and policies;
    • Specific experience in medical Devices, IVD, and POC devices
    • Regulatory agency structure, processes and key personnel; and
    • Ethical guidelines of the regulatory profession, clinical research and regulatory process.
  • Must have ability to handle multiple projects in a fast-paced environment and exercise sound judgment.
  • Must have demonstrated ability to manage a small team, and to perform successfully in cross-functional teams, with the ability to lead and mentor.
  • In addition to top-notch technical expertise, must have excellent interpersonal, strategic thinking, communication and organizational skills.

Qualifications

  • Preferable 10 years direct management experience.
  • Extensive experience with US and international regulatory strategy.
  • Significant experience interacting and negotiating with FDA, specifically the Division of Chemistry and Toxicology Devices within the Center for Devices and Radiological Health’s OHT7, Emergency Use submissions, and others

Additional Details

**Send a cover letter and CV to recruiting@e25bio.com**

About E25Bio

Fever syndromes account for over 1 billion episodes annually and are one of the most common reasons to seek care worldwide. For the nearly 3 billion people who live in the equatorial belt a high fever can signal the onset of potentially deadly infectious diseases. We diagnose fevers with simple, yet robust Rapid Diagnostic Tests. Existing solutions rely heavily on centralized laboratory equipment and trained staff, cold chain for specimen transport, and hub-and-spoke reporting mechanisms for data. Our innovations aim to provide people with a much simpler alternative: to identify infectious diseases in time to avoid serious complications and death. Through early and accurate screening, we can help equip the right patient with the right treatment at the right time.

Founded by Dr. Irene Bosch, Dr. Bobby Brooke Herrera, and MIT Professor Lee Gehrke, E25Bio is a Tough Tech company at The Engine (MIT) in Cambridge, MA, where our office and laboratory is located.

E25Bio is committed to providing equal employment opportunities in all employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship status, marital status, age, disability, protected veteran status, sexual orientation or any other characteristic protected by law.

Want to know more?

 

Meet the team with who you will potentially work with on preventing the spread of epidemic fever viruses.

Meet the team