1 of 1 Marketing Jobs in Bala

is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the global CMC regulatory strategy and regulatory activities to bring products in development through global marketing authorization approval and launch. The Regulatory Affairs Director will be a key member of project teams and the role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities … the regulatory, clinical project, and technical operations (cross-functional) teams who will manage CMC regulatory aspects of projects related to global clinical trials, global health authority interactions and global marketing submissions and approvals. This person will work independently, and as a member of a team. Liaise internally with other members of the Regulatory Affairs department to coordinate the timely submission … authoring and review) of high-quality regulatory documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and Global marketing authorization applications. Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Ability and willingness to work onsite, while maintaining strong collaboration in a More ❯