What are the responsibilities and job description for the Director, CMC Regulatory Affairs position at AstraZeneca GmbH?
The Director, CMC Regulatory Affairs is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position can be based in Santa Monica, CA, San Francisco, CA or Gaithersburg, MD and reports to the Executive Director, CMC Regulatory Affairs.
Responsibilities
- Provide strategic guidance during all stages of product development and lead the development and implementation of global CMC regulatory strategies for the pipeline of AZ products.
- Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams.
- Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / BLA / Master Files, amendments, annual reports) and health authority interaction briefing documents. Manage and maintain regulatory dossiers as required throughout the product development lifecycle.
- Represent CMC regulatory affairs on product teams and in health authority interactions.
- Provide review and compilation and ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
- Provide regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises.
- Support the development and maintenance of regulatory templates, best practices, and procedures.
- Perform other duties as required.
Supervisory duties
Skills / Abilities
Education and Experience
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