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.
The Manager CMC Regulatory Affairs is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early and late-stage T cell therapies. This position is hybrid and reports to the Sr. Director, CMC Regulatory Affairs.
What you will do:
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 / Master Files, amendments, annual reports) and health authority interaction briefing documents. Manage and maintain regulatory dossiers as required throughout the product development lifecycle.
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.
Support the development and maintenance of regulatory templates, best practices, and procedures.
Perform other responsibilities.
Supervisory Responsibilities
Support hiring, leading and managing workflow.
Education and Experience
BA/BS degree in life sciences required, advanced degree preferred (PhD,MS, PharmD).
Experience of 8+ years with BS/BA; 6+ years with MS/MA or MBA; 5+ 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 $128,651 to $144,733. 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
Date Posted
19-Sep-2024Closing Date
03-Oct-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.