Regulatory Submissions Specialist (Hybrid)

Technical Resources International, Inc.; Bethesda (MD); Hybrid; USD 75,000 - 85,000; Full time

Job summary

A regulatory affairs organization in Bethesda is seeking a Regulatory Specialist to manage regulatory submissions and scientific document preparations. The role requires a Bachelor's Degree and strong communication skills. Candidates should have knowledge of Microsoft Office and GCP. This hybrid position offers 2 days on-site and 3 days remote work. The salary ranges from $75,000 to $85,000 annually.

Qualifications

• Excellent oral and written communication skills; detail-oriented.
• Ability to analyze medical research data and review protocols.
• Experience in preparing regulatory documents and submissions.

Responsibilities

• Prepare and track regulatory submissions including INDs and BLAs.
• Prepare scientific documents for the FDA and other Health Authorities.
• Attend scientific meetings to stay updated on developments.

Skills

Excellent oral and written communication skills

Detail-oriented and able to multi-task/prioritize

Ability to analyze medical research data

Strong working knowledge of Microsoft Office

Familiarity with GCP

Education

Bachelor's Degree

Tools

Microsoft Office

SharePoint

Job description

A regulatory affairs organization in Bethesda is seeking a Regulatory Specialist to manage regulatory submissions and scientific document preparations. The role requires a Bachelor's Degree and strong communication skills. Candidates should have knowledge of Microsoft Office and GCP. This hybrid position offers 2 days on-site and 3 days remote work. The salary ranges from $75,000 to $85,000 annually.