FDA Regulatory Managing Scientist
About The Position
Exponent is the only premium engineering and scientific consulting firm with the depth and breadth of expertise to solve our clients’ most profoundly unique, unprecedented, and urgent challenges. We are committed to engaging multidisciplinary teams of science, engineering, and regulatory experts to empower our clients with solutions that create a safer, healthier, more sustainable world. For over five decades, we've connected the lessons of past failures with tomorrow's solutions to advise clients as they innovate technologically complex products and processes, ensure the safety and health of their users, and address the challenges of sustainability. Join our team of experts with degrees from top programs at over 500 universities and extensive experience spanning a variety of industries. At Exponent, you’ll contribute to the diverse pool of ideas, talents, backgrounds, and experiences that drives our collaborative teamwork and breakthrough insights. Plus, we help you grow your career through mentoring, sponsorship, and a culture of learning. Thanks for your interest in joining our team! We are currently seeking an FDA Regulatory Scientist for a Manager-level position for our Chemical Regulation and Food Safety Practice to be based in our Washington, DC office. Other locations may be considered. In this role you will work as part of a team providing a high level of project management, technical expertise, and project support to the consultants in the Chemical Regulation and Food Safety Practice in relation to US Food and Drug Administration drug filings.
Requirements
- Master’s or Ph.D. degree in a science-related field
- Five (5) or more years of The Federal Food, Drug, and Cosmetic Act (FFDCA) regulatory experience.This position requires knowledge, solid understanding, and practical experience with U.S. FDA/FFDCA regulations for human and animal drugs.
- Excellent oral and written communication skills, including the ability to independently prepare, edit, and proofread technical and regulatory documents
- Must be detail-oriented, able to work independently, and manage time effectively
- Strong ability to organize and prioritize multiple projects with competing deadlines
- Excellent interpersonal skills and ability to work in a collaborative environment
- Presently legally authorized to work in the United States. No immigration sponsorship or processing required.
Nice To Haves
- Consulting experience preferred (but not required)
- Experience with project management, budget tracking, and invoicing a plus
- Exposure to sensitive information will necessitate considerable use of tact, diplomacy, discretion, and judgment
- Entrepreneurial spirit is a plus
Responsibilities
- Provide regulatory and technical strategy related to Food and Drug Administration (FDA) approval for new and generic drugs (human and/or animal)
- Author, compile, and submit regulatory filings for New Drug Applications, Investigational Drug Applications, Abbreviated New Drug Applications, and New Animal Drug Applications
- Evaluate and synthesize technical and regulatory information in support of applications
- Draft, edit, and proofread complex regulatory and technical reports
- Engage directly with clients and regulators throughout the strategy development, application submission, and review process for new and generic drugs
- Manage and track client projects, project deliverables, invoices, and budgets
- Participate in developing business and marketing to clients
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
