Regulatory & Scientific Analyst — FDA Submissions Expert

National Science Foundation; Montgomery Village (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

The National Science Foundation seeks a Regulatory Scientific Analyst / Regulatory Affairs Manager to prepare, review, and coordinate regulatory submissions for the FDA and other agencies. You will contribute to regulatory strategy, document preparation, and cross‑functional collaboration.

Responsibilities may include advanced regulatory coordination, FDA meeting preparation, and departmental support, requiring strong writing, analytical skills, and the ability to work independently and with

Qualifications

• Master’s degree in biological sciences or related field is required.
• Experience with regulatory submissions and clinical study documents.
• Strong written and verbal communication skills are essential.
• Ability to work both independently and collaboratively.

Responsibilities

• Prepare, develop, write, review, and coordinate regulatory documents for FDA and other agencies.
• Contribute to regulatory strategy and scientific analysis across cross-functional teams.
• Coordinate advanced regulatory activities and FDA meeting preparation where applicable.
• Provide departmental support and ensure timely regulatory deliverables.

Skills

Scientific writing

Regulatory submissions

Regulatory coordination

Communication skills

Independent & collaborative work

Education

Master’s degree in biological sciences or related field

PhD, PharmD or MD

Tools

MS Word

Excel

PowerPoint

MS Visio

Job description

The National Science Foundation seeks a Regulatory Scientific Analyst / Regulatory Affairs Manager to prepare, review, and coordinate regulatory submissions for the FDA and other agencies. You will contribute to regulatory strategy, document preparation, and cross‑functional collaboration.

Responsibilities may include advanced regulatory coordination, FDA meeting preparation, and departmental support, requiring strong writing, analytical skills, and the ability to work independently and with