Remote Regulatory Specialist ($28.00 - $31.25 / Hour)

Join employer and be part of a company that values diversity, inclusion, and growth opportunities. With a network of engineering and science consultants and Fortune 500 clients, employer provides the platform to advance your career and make a meaningful impact in the industry.

Job Responsibilities

• Handle required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), NCI, and FDA.
• Review and edit policies.
• Prepare and process regulatory documentation through IRB, CTSRMC, FDA, and other regulatory review committees.
• Submit to IRB a minimum of 10 times.
• Process initial regulatory documents for submission to Pharmaceutical Sponsors and Institutional Review Board (IRB).

Qualifications

• Bachelor's Degree and 3-5 years of relevant experience or equivalent combination of education and experience.
• Strong writing skills.
• Experience with IND/IDE/Clinical Trial Application.
• Knowledge and experience with FDA Clinical Trial regulations and guidance.
• 3 years of relevant experience in an academic regulatory environment.

Additional Information

At employer, diversity and inclusion are important values that drive our success. We are an equal opportunity employer.

About Employer

employer connects passion with purpose, helping companies advance their engineering and science initiatives through specialized experts. With a wide network of consultants and Fortune 500 clients, employer is a leader in talent solutions. Launched in 2021, employer is part of Allegis Group.

Talentify helps candidates around the world to discover and stay focused on the jobs they want until they can complete a full application in the hiring company career page/ATS.