Associate Director, CMC Regulatory Affairs (Cell & Gene Therapies)

The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell & Gene Therapies. This position is hybrid, and may be based in Santa Monica, CA, Gaithersburg, MD or Boston, MA and reports to the Senior Director, CMC-CGT Regulatory Affairs.

Essential Functions and 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.
• Support Reg CMC activities in 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.
• Support the development and maintenance of regulatory templates, best practices, and procedures.
• Deliver “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality

Supervisory Responsibilities

• Support hiring, leading workflow and development of staff.

Required Skills/Abilities

• Demonstrated ability to develop/maintain strong working relationships with the 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.
• Proficient leadership skills to successfully lead complex programs. Able to effectively build and lead high-functioning teams.
• Ability to deal with time demands, incomplete information or unexpected events
• Attention to detail required.
• Outstanding organizational skills with the ability to multi-task and prioritize
  

Education and Experience

• Experience of a minimum of 8 years with a Master's degree in life sciences or 6 years with a PhD.
• Prior experience in cell/gene therapy is preferred.
• Knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.
• Experience in IND, IMPD, BLA, and MAA filings is preferred.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being ambitious - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking methods, and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next?

Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

The annual base pay (or hourly rate of compensation) for this position ranges from $135,624.80 - $203,437.20 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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 (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). 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

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.