[Remote] CMC Regulatory Affairs Specialist – Fractional CMC Submission Author
Note: The job is a remote job and is open 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 critical manufacturing compliance impact. 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 focus • Technical support tools Company Overview • 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 Apply tot his job