FDA Regulatory Managing Scientist

About Exponent 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! Key statistics: 950+ Consultants 640+ Ph.D.s 90+ Disciplines 30+ Offices globally Our Opportunity 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. You will be responsible for 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 You will have the following skills and qualifications 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. Consulting experience preferred (but not required) 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 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 Presently legally authorized to work in the United States.No immigration sponsorship or processingrequired. Applicants are encouraged to submit a CV with publications (feel free to include publications that are in review or pending) [not restricted to 1 page]. Life @ Exponent To learn more about life at Exponent and our impact, please visit the following links: Attracting, inspiring, developing, and rewarding exceptional people with diverse backgrounds and expertise are central to our corporate culture. Our diverse team allows us to provide better value to our clients and enjoy an enriched work environment. Our firm is committed to offering a variety of programs and resources to support health and well-being. We believe that providing competitive benefits as well as compensation and recognition programs empowers our staff to do work that makes a difference. Work Environment At Exponent, we have found that in-person interactions deepen employee engagement and are crucial to our development, for realizing the full potential of our talented and diverse teams, and for building a more inclusive workplace where all have a sense of belonging. In our offices, you can expect a supportive culture and a collaborative, dynamic, multi-disciplinary work environment. Our consultants engage in-person in the office unless they are traveling for client work or other business activities. We value the rich lives our colleagues enjoy outside of work and understand that work/life balance is critical to our employees and their well-being. Consultants have the autonomy to balance their work and personal schedules so you can meet with clients, visit inspection sites, attend conferences, and make time for priorities outside of work, too. It is this flexible, agile work style and working hours that allow our teams to drive innovation and results in their own ways, while meeting the needs of clients. #LI-Onsite Compensation Our consultants are rewarded for their technical and business contributions and have an opportunity to plan for future success and career growth. Exponent's total compensation plan is consistent with its expectations of the quality and quantity of work performed and with the professional standards set by Exponent. At the Manager level and above total compensation includes base salary, annual bonus, and 401(k) employer contribution of 7% of base salary. The base salary range for this position is dependent on experience and capabilities which will be assessed during the interview process. Salary Range USD $127,000.00 - USD $156,000.00 /Yr. Benefits you will enjoy Access benefits information on our View email address on click.appcast.io page: Exponent is a proud equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status. If you need assistance or accommodation due to a disability, you may email us at View email address on click.appcast.io. Job Locations US-Washington, DC #J-18808-Ljbffr Exponent