Regulatory Affairs Consultant
Job Summary
Seeking a part-time Regulatory Affairs Consultant, this remote contract position will manage regulatory content standards, ensuring compliance with agency expectations and readiness for global submissions while working approximately 5-20 hours per week.
Key responsibilities
- Define and uphold regulatory content standards for submissions
- Engage in knowledge sharing about regulatory workflows and AI integration
- Review and generate reference artifacts to evaluate data quality and discrepancies
Required qualifications
- 10+ years of experience in Regulatory Affairs within the pharmaceutical/biotechnology industry
- Bachelor's Degree required; Advanced degree preferred
- Strong understanding of regulatory requirements, ICH guidelines, and FDA/EMA expectations
- Experience with IND filings and familiarity with NDA/BLA, MAA submissions is a plus
Complete Job Description
The complete job description is available to members. Premium membership includes:
Full access to 44,891 remote jobs from human-vetted companies, updated daily
Resume Builder - AI-powered tool to craft, enhance, and tailor your resume to a specific job
Twice-monthly live group coaching and the full Remote Career Center
20% member discount on Career Services
Backed by a 30-day money-back guarantee
Company Company Name
Headquarters Headquarters
Founded Founded
Website
The company description is available to members. Go Premium for full access to every job and company profile in our remote jobs database, backed by a 30-day money-back guarantee.
