Associate Director, Regulatory Affairs - CMC

AstraZeneca • Santa Monica, CA, United States • $200k - $250k / year • 1m ago

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, ensuring 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.

Work Environment

In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. We work, on average, a minimum of three days per week from the office while balancing the expectation of being in the office with individual flexibility.

Compensation

The annual base salary for this position ranges from $128K to $176K, depending on multiple individualized factors, including market location and job-related experience.

Benefits

Short-term incentive bonus opportunity
Equity-based long-term incentive program
401(k) plan
Paid vacation and holidays; paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage.

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