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 based in Gaithersburg, MD and reports to the Senior Director, CMC Regulatory Affairs CGT.

Essential Functions and 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 author, review and 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 appropriate CMC teams. Ensure the delivery of submission documentation which is fit for the intended purpose with appropriate consideration of the desire for subsequent operational flexibility.

• 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.

• Provide support for regulatory submissions, maintenance

• You will support the development and maintenance of regulatory templates, best practices, and procedures.

• AstraZeneca drives business performance through continuous improvement, we therefore expect all employees to: 1) Follow processes and work to standards, 2) Identify and solve problems 3) Define and implement improvements. Leaders will lead by example in creating a learning & continuous improvement culture.

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.

• 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 ten (10) years with a Bachelor’s degree in life sciences or 8 years with a Master’s 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.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

The annual base pay (or hourly rate of compensation) for this position ranges from $135,182.40 – 202,773.60 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 factors.