MedFocus Regulator Affair CMC Assoc III in California
Job Description: This position focuses on the management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs. The role involves working closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, amendments, supplements/ variations, and other CMC-oriented filings. Expertise with biologics and/or drug/biologic/device products is strongly preferred. This position is also responsible for obtaining and interpreting CMC regulations and guidance and providing regulatory advice to technical operations departments. Strong communication and management skills are required.
Oversee planning, preparation, and submission of the CMC sections of marketing applications globally.
Ensure that the sections are accurate, complete, well-written, and meet all relevant country-specific requirements.
Develop excellent relationships with internal functional groups, contract manufacturing organizations, and partners.
Researching and interpreting global CMC regulations and providing regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups.
Education: Bachelor’s degree in chemistry, biology, biochemistry or related field. Skills:
Excellent organization skills.
Attention to detail.
Understanding of ICH guidances and CMC regulations.
Min Salary: $0.00
Max Salary: $0.00