Associate Director, Regulatory Affairs - CMC (Cell Therapy)
Associate Director, Regulatory Affairs - CMC (Cell Therapy)
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$ 135 - 200
1 Vacancy
Job Description
Position Summary
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 or Gaithersburg MD and reports to the Senior Director CMC-CGT 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
Experience of a minimum of ten (10) years with a Bachelors degree in life sciences or 8 years with a Masters degree or 6 years with a 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.
#celltherapy
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. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 $135K to $200K. However 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 salary (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.
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.
#LI-Hybrid
Date Posted
28-May-2025Closing Date
26-Jun-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.Required Experience:
Director
Employment Type
Full-Time
