cmc regulatory affairs specialist.

- Support the development of the CMCD (Chemistry, Manufacturing, and Controls Development) strategy for certain products of the business unit, both mature and new launch, to ensure globally approvable dossiers.- Responsibility is shared across global and local markets.- Work closely with Regulatory to develop effective Regulatory and CMC strategies.- Collaborate with R&D, Product Supply, and Regulatory to ensure the timely compilation of high-quality CTD Module 3 and QOS documents.- Support responses to Quality questions from Regulatory Health Authorities.- Effectively manage post-approval change and product lifecycle.- Drive continuous improvement.- Maintain and implement knowledge of current industry requirements and best practices for CTD Module 3 and QoS or equivalent. ...