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

AstraZeneca • Gaithersburg, MD

9d • Hybrid

About The Position

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.

Requirements

• 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.
• 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.

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees