Regulatory Specialists & Project Managers

Job Description

The Weinberg Group, the leading FDA consultancy, is growing and looking for regulatory professionals of all levels to join our staff. Successful candidates will have at least a master’s degree in a scientific field and a minimum of four years of hands on regulatory experience preparing and/or reviewing FDA submissions of any kind. Excellent communication skills are expected.  The ability to work in our Washington, DC office is preferred, but telecommuting is also acceptable.

 Responsibilities Include:
  • Working with clients to develop regulatory strategies and plans for FDA
  • Crafting, writing, and editing regulatory submissions
  • Working with an internal project team and client to meet regulatory deadlines, respond to FDA issues and assure integrity of submissions
  •  Providing advice on drug development strategies
Desired Skills:
  • Understands the client’s problem; conceptualizes how to solve it and achieve task objectives
  • Contributes scientific and innovative thinking
  • Contributes significantly to a high-quality work product acceptable to the project manager, on time, and within budget
  • Effectively manages deadlines, multi-tasks, works, and remains calm under pressure
  • Demonstrates excellent communication skills — written and oral
 Essential Qualifications:
  • 5-10 years’ experience in the creation or analysis of FDA submissions
  • Bachelor degrees in a science field necessary, master’s preferred
  • Demonstrated knowledge of FDA requirements

Interested candidates should send a copy of your cover letter and CV to regulatory.careers@weinberggroup.com for consideration.

About Us

For the past 32 years, The Weinberg Group has assisted pharmaceutical and biotechnology clients in the development and implementation of successful and innovative regulatory strategies. In addition, we have worked with hundreds of companies to remediate, maintain, and improve their regulatory compliance.

The Weinberg Group offers a very competitive salary and benefits package that includes medical, dental, STD, LTD, a selection of voluntary benefits, 401(k) plan with a generous matching contribution, and tuition reimbursement.  We are an equal opportunity employer.