Associate Director, Regulatory Affairs

2 months ago

Santa Monica, United States Neogene Therapeutics Full time

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

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

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.

#LI-Hybrid

DE&I Statement

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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