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Exponent

Multidisciplinary science and engineering consulting

FDA CVM Regulatory Managing Scientist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeWashington, DC, USA

About the Job

Requirements

  • A Ph.D. or Master's degree in a science-related field is required; a DVM is preferred.
  • At least five years of FDA CVM or FFDCA regulatory experience is required, including knowledge, understanding, and practical experience with U.S. FDA CVM/FFDCA animal-drug regulations.
  • Ability to independently prepare, edit, and proofread technical and regulatory documents.
  • Ability to work independently and manage time effectively.
  • Ability to organize and prioritize multiple projects with competing deadlines.
  • Ability to work collaboratively and exercise tact, diplomacy, discretion, and judgment when handling sensitive information.
  • Presently legally authorized to work in the United States; immigration sponsorship or processing is not provided.

Responsibilities

  • Provide high-level regulatory and technical strategy for FDA CVM approval of 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.
  • Apply expertise in relevant FDA CVM technical areas, including CMC, effectiveness, target animal safety, human user safety, and labeling.
  • Evaluate and synthesize technical and regulatory information supporting FDA CVM submissions, including new registrations, supplemental applications for registered animal drugs, and ongoing stewardship requirements.
  • Draft, edit, and proofread complex regulatory and technical reports.
  • Engage directly with clients and regulators throughout strategy development, application submission, and review for new and generic drugs.
  • Manage and track client projects, deliverables, invoices, and budgets.
  • Participate in business development and marketing to clients.

Desired Qualifications

  • Consulting experience is preferred but not required.
  • Experience with project management, budget tracking, and invoicing is a plus.
  • An entrepreneurial spirit is a plus.

About the Company

Exponent

Multidisciplinary science and engineering consulting

Exponent is a consulting firm that applies scientific and engineering expertise to help businesses, communities, and individuals solve complex problems and navigate change. Its team of over 950 consultants works across many industries and regions, offering multidisciplinary analysis and testing methods to develop actionable solutions. Revenue comes from fees for consulting services, tied to the ability to attract and retain clients and deliver effective results. Exponent differentiates itself through broad, cross-disciplinary capabilities, state-of-the-art testing, and a focus on technically solid, practically applicable outcomes. The company’s goal is to help clients address difficult challenges with rigorous, evidence-based guidance and to support them as they adapt to changing circumstances.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Fishers, IN
Founded
1967

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