CMC Regulatory Affairs Director
Virtual Vocations Inc, New York, NY, United States
A company is looking for an Associate Director in Global Regulatory Affairs, CMC, Gene Therapy.
Key Responsibilities
Lead CMC regulatory activities for complex projects and provide expertise to global project teams Manage the preparation and review of global registration packages to ensure compliance with regulatory requirements Oversee global submissions and ensure timely compilation and transmission of regulatory documents
Required Qualifications
BS in Chemistry or equivalent degree 10 years of industry experience, with at least 6 years in Regulatory Affairs or CMC regulatory roles Experience with global regulatory aspects of CMC across multiple dosage forms Knowledge of EU, US, and/or Japan regulations for NCEs and product life cycle maintenance Ability to work in a cross-functional and international environment
Lead CMC regulatory activities for complex projects and provide expertise to global project teams Manage the preparation and review of global registration packages to ensure compliance with regulatory requirements Oversee global submissions and ensure timely compilation and transmission of regulatory documents
Required Qualifications
BS in Chemistry or equivalent degree 10 years of industry experience, with at least 6 years in Regulatory Affairs or CMC regulatory roles Experience with global regulatory aspects of CMC across multiple dosage forms Knowledge of EU, US, and/or Japan regulations for NCEs and product life cycle maintenance Ability to work in a cross-functional and international environment