Job Details

A company is looking for an Associate Director in Global Regulatory Affairs, CMC, Gene Therapy.Key ResponsibilitiesLead CMC regulatory activities for complex projects and provide expertise to global project teamsManage the preparation and review of global registration packages to ensure compliance with regulatory requirementsOversee global submissions and ensure timely compilation and transmission of regulatory documentsRequired QualificationsBS in Chemistry or equivalent degree10 years of industry experience, with at least 6 years in Regulatory Affairs or CMC regulatory rolesExperience with global regulatory aspects of CMC across multiple dosage formsKnowledge of EU, US, and/or Japan regulations for NCEs and product life cycle maintenanceAbility to work in a cross-functional and international environment