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, and 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.

• You will 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 and 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.

• You will support the development and maintenance of regulatory templates, best practices, and procedures.

Supervisory Responsibilities

• Support hiring, leading workflow and development of staff.

• You will 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.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $128K to $176K. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Benefits

#LI-Hybrid

Date Posted

13-Sep-2024

Closing Date

27-Nov-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.