Position Summary
The AD CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is hybrid, based in Santa Monica, CA, and reports to the Executive Director, CMC Regulatory Affairs.
Responsibilities
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 regulatory dossiers throughout the product development lifecycle.
Lead complex programs.
Provide review and compilation to ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
Represent CMC regulatory affairs on product teams and in health authority interactions.
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.
Supervisory Responsibilities
Support hiring, leading workflow, and development of staff.
Build and lead high-functioning teams.
Education and Experience
MA/MS degree in life sciences required, advanced degree preferred (PhD, PharmD).
Experience of 10+ years with BS/BA; 8+ years with MS/MA or MBA; 6+ years with PhD.
Prior experience in cell/gene therapy.
In-depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.
Experience in IND, IMPD, BLA, MAA filings.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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