FDA CVM Regulatory Managing Scientist (D.V.M, Ph.D., or M.S.)

Exponent Inc. • Washington, DC

1d • $127,000 - $156,000 • Onsite

About The Position

Exponent is seeking an FDA CVM Regulatory Scientist for a Managing Scientist level position within their Chemical Regulation and Food Safety Practice. This role will be based in Washington, DC, though other locations may be considered. The primary responsibility is to provide high-level FDA CVM guidance, project management, technical expertise, and project support to consultants in relation to US Food and Drug Administration Center for Veterinary Medicine drug filings. The position involves working as part of a team to deliver expert support for animal drug approvals.

Requirements

• DVM (preferred), Ph.D., or Master’s degree in a science-related field
• Five (5) or more years of FDA CVM or the Federal Food, Drug, and Cosmetic Act (FFDCA) regulatory experience
• Knowledge, solid understanding, and practical experience with U.S. FDA CVM/FFDCA regulations for 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
• Experience with project management, budget tracking, and invoicing a plus
• Entrepreneurial spirit is a plus

Responsibilities

• Provide high-level regulatory and technical strategy related to Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) approval for new and generic animal drugs
• Author, compile, and submit regulatory filings for New Animal Drug Applications, Investigational New Animal Drug files, Abbreviated New Animal Drug Applications, Supplemental New Animal Drug Applications, and Conditional New Animal Drug Applications
• Expertise in some or all relevant FDA CVM technical areas, including CMC, effectiveness, target animal safety, human user safety, and labeling
• Evaluate and synthesize technical and regulatory information in support of FDA CVM submissions, including but not limited to new registrations, supplemental applications to registered animal drugs, and ongoing stewardship requirements
• 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

Benefits

• Base salary, annual bonus, and 401(k) employer contribution of 7% of base salary (for Manager level and above)
• Mentoring, sponsorship, and a culture of learning
• Competitive benefits, compensation, and recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Manager