Global Cmc Regulatory Affairs Director
CurrentWorking within CMC Regulatory Affairs I'm responsible for developing global CMC regulatory strategies and content plans and ensures the development strategy meets global regulatory requirements over the lifecycle of the product. Confirms the CMC regulatory strategy is in alignment with the global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Target Product Profile (TPP). Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader). Participates as the Regulatory CMC Lead on CMC Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise on the CMC Core Team and Global Regulatory Team (GRT) to facilitate successful product development globally and to provide input on team recommendations. Refines regulatory strategies as new data become available. Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product. Leads the preparation of regulatory dossiers for submission to Health Authorities. Actively participates on Global Regulatory Team(s) to develop global marketing approval submission plans. Provides accurate regulatory assessments of chemistry manufacturing and control changes to teams and executes regulatory planning and implementation.
