The opportunity
The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help develop regulatory strategies to support development of innovative biologic products, as well as to ensure efficient management of approved and marketed products. The responsibilities of the role include influencing the strategy and assessing the quality of documents for regulatory submissions to major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for global registration.
This position comes with 4 direct reports (Dir, Sr Manager, Manager & Associate III).
The Sr Director, Regulatory Affairs CMC is responsible for identifying and evaluating CMC issues associated with product development including product and process development, device development, analytical methods, formulation development, manufacturing, and labeling.
The Sr Director, Regulatory Affairs CMC is also responsible for the oversight of maintaining and updating CMC sections of submissions for Teva products, and for ensuring the quality of CMC response to global health authorities. The individual will interface with development, analytical, quality and manufacturing groups across the Teva network, as well as with internal regulatory departments. The Sr Director, Regulatory Affairs CMC will oversee cross functional product teams for CMC specific projects and contribute to the planning and conduct of meetings with FDA.
The ideal candidate for this role will work out of our West Chester, PA office
How you’ll spend your day
Major Duties and Responsibilities
⦁ Responsible for the oversight of the entire biologic antibody portfolio at Teva (both development and marketed products)
⦁ Provide accurate and timely CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidances and directives, and evaluating and communicating their applicability to the development teams.
⦁ Develop and communicate effective CMC regulatory strategies for development and post marketing submission activities. Determine and communicate appropriate risk analyses and timeline development.
⦁ Coordinate, author and review the CMC sections of IND, NDA and CTA filings. Compile and review CMC regulatory documents, including but not limited to Development Reports, Validation Protocols and Reports, NDA supplements, IND and NDA Annual Reports, and Responses to FDA information requests. Assist in the submission of regulatory correspondence to the FDA.
⦁ Support the global registration initiative for marketed products by liaising with Regulatory counterparts in Europe, Israel, Canada and Rest of World assisting with preparation of complete registration dossiers to be submitted to foreign Health Authorities.
⦁ Lead the review of internal CMC controlled documentation including but not limited to standard operating procedures, test methods, specifications and protocols
⦁ Perform change management to establish the regulatory impact of changes and ensure compliance of registered commitments.
⦁ Assist in planning and conducting meetings with regulatory agencies for routine meetings and interactions.
