Regulatory Affairs Manager

Gaithersburg, MD
Mar 15, 2021
Required Education
Masters Degree/MBA
Position Type
Full time

Regulatory Affairs Manager Job Summary

Our pharmaceutical and medical device company is seeking a Regulatory Affairs Manager to provide support as we expand our product line. In this role, your primary responsibility is to oversee regulatory submissions, ensuring they are compliant with FDA regulations as well as the guidelines set by other relevant regulatory bodies. As part of this process, you will prepare and file submission documents, including ANDAs, amendments, supplements, annual reports, and 505(b) files. You will also assist with external audits and respond to any complaint documentation regarding our devices.

Regulatory Affairs Manager Duties and Responsibilities

  • Prepare and file regulatory submissions (ANDAs, amendments, supplements, annual reports, 505(b)(2) and 505(b)(1) files)
  • Perform assessments of new or revised products
  • Manage complaint documentation (including investigation and closure)
  • Respond to inquiries from regulatory bodies, including the FDA
  • Perform or facilitate audits to ensure compliance
  • Collaborate with project team members to obtain documentation and establish timelines
  • Improve internal processes to reduce risk

Regulatory Affairs Manager Requirements and Qualifications

  • A bachelor’s degree in life sciences or a technical field (required)
  • A master’s degree in regulatory affairs a plus
  • RA certification in the U.S. or EU (preferred)
  • Regulatory experience in the industry (5-10 years preferred)
  • Up-to-date knowledge of international, federal, and state guidelines
  • Sound judgment
  • Organizational and communication skills
  • Attention to detail