Regulatory Specialist

Job Description

The Weinberg Group, the leading FDA consultancy, is growing and looking for experienced regulatory specialists to join our staff. The ideal candidate will have a master’s degree in regulatory affairs or a scientific field and a minimum of five years of hands on regulatory experience preparing and/or reviewing FDA submissions of any kind. Excellent communication skills are expected, as is the ability to work in our Washington, DC office.

 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 – 7 years’ experience in the creation or analysis of FDA submissions
  • Master’s degrees in regulatory affairs or a science field is required
  • Hands on regulatory experience developing FDA submissions
  • Demonstrated knowledge of FDA requirements

Interested candidates should send a copy of your cover letter and CV to for consideration.

About Us

For the past 35 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.