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 CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all Regulatory CMC technical writing objectives are met for the innovative pipeline of early and late-stage T cell therapies. The role reports to the Senior Director, CMC Regulatory Affairs and may be based in Santa Monica, CA or Gaithersburg, MD.

Accountabilities

Author the CMC sections of regulatory documents (e.g., IND/IMPD, BLA/MAA, health authority questions, briefing documents) to support the timely submissions of investigational and marketing applications.

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.

Ensure submissions are complete and accurate and comply with applicable regulatory requirements and expectations.

Support the development and maintenance of regulatory templates, best practices, and procedures.

Perform other responsibilities.

Support hiring, leading, and managing workflow.

Essential Skills

Demonstrated ability to develop/maintain strong working relationships with cross-functional teams, participate on and/or lead multi-functional teams, handle, and prioritize multiple projects and work independently.

Excellent communication and collaboration skills to work in a fast-paced start-up environment.

Ability to deal with time demands, incomplete information or unexpected events.

Attention to detail with the ability to multi-task and prioritize.

Education and Experience

BA/BS degree in life sciences required, advanced degree preferred (MS, PharmD).

Experience of 8+ years with BS/BA; 6+ years with MS/MA.

Prior experience in cell/gene therapy.

The candidate must possess Chemistry, Manufacturing and Controls (CMC) and CTD experience.

The candidate must have CTD Module 3 authoring skills.

Experience in IND, IMPD, BLA, MAA filings.

#CellTherapy

#LI-hybrid

The annual base pay for this position ranges from $105,841 to $155,762.  Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as 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.

When we put unexpected teams in the same room, we unleash 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.

At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. Here we thrive in our inclusive, diverse, and bold environment. We draw on our diverse knowledge to take smart risks and uncover new and creative ways to deliver better for our patients and our business.

Ready to make a difference? Apply now!

Date Posted

06-Feb-2025

Closing Date

15-Mar-2025Our 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.