Job Details

A company is looking for a Director, Regulatory Affairs - CMC.Key ResponsibilitiesServe as a technical expert in development, testing, and manufacturing of Biologics and provide advice to colleagues and clientsManage the preparation of regulatory CMC submission documents and facilitate submission approvals through effective communicationMonitor new regulatory requirements and provide strategic advice to clients based on regulatory experienceRequired Qualifications and EducationBachelor's degree in a relevant discipline, preferably in life sciences or healthcareAdvanced degree (MSc., PhD., M.D., Pharm.D., MBA) in a related field is beneficialRelevant experience in pharmaceutical or biologics regulatory environments (e.g., US, EU, Canada)Demonstrable experience in a regulatory CMC role during drug development and product maintenanceCertification in regulatory affairs (RAC) or relevant post-secondary education is beneficial