Job Summary
A pharmaceutical and biotech company needs applicants for an opening for a Remote Regulatory Affairs CMC Director or Senior Director.
Core Responsibilities of this position include:
- Assessing data with technical and functional expertise to solve problems
- Understanding, interpreting, and advising on regulations, guidelines, and procedures relating to CMC development
- Preparing and managing CMC RA content for submissions
Must meet the following requirements for consideration:
- B.S. degree required
- Minimum of 13 years of experience in CMC Regulatory Affairs or related experience
- Successful MAA and NDA submission experience
- Ability to analyze and interpret scientific data and regulations to apply to a rare disease program
- Experienced in Regulatory Agency meetings resulting in successful outcomes
- Knowledge and practical understanding of ICH and EMA Guidelines regarding GMP/GCP and CTD/eCTD, and US FDA CDER requirements
