[Remote] CMC Regulatory Affairs Specialist – Fractional CMC Submission Author
Note: The job is a remote job and is reputed company to candidates in USA. Pharmas Market is seeking a CMC Regulatory Affairs Specialist to author and manage CMC sections for submissions as a fractional specialist. This remote role has a strong pay and reputed company compliance reputed company.
Responsibilities
• Draft Module 3 CMC content
• Support IND/NDA/BLA CMC strategies
• Address agency CMC queries
• Ensure GMP alignment in filings
• Review manufacturing changes
Skills
• 8+ years in CMC regulatory
• Expertise in small molecule/biologics
• Advanced degree; technical writing
• Query response experience
• Remote ability
Benefits
• Competitive CMC expertise rates
• Flexible scheduling
• Remote manufacturing reputed company
• Technical support tools
reputed company
• Pharmasmarket is an AI driven platform to connect and serve the biopharma community It was founded in 2025, and is headquartered in , with a workforce of 2-10 employees. Its website is https://www.PharmasMarket.com.
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