Associate Director, CMC Regulatory Affairs (Cell & Gene Therapies)
AstraZeneca
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, Gaithersburg, MD or Boston, MA and reports to the Senior Director, CMC-CGT Regulatory Affairs.
Job description
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.
Requirements
- Minimum of 8 years of experience with a Master's degree in life sciences or 6 years with a PhD
- Knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies
- Demonstrated ability to develop/maintain strong working relationships with cross functional teams
- Ability to participate on and/or lead multi-functional teams
- Ability to handle and prioritize multiple projects and work independently
- Excellent communication and collaboration skills
- Proficient leadership skills to lead complex programs and build high-functioning teams
- Ability to deal with time demands, incomplete information or unexpected events
- Attention to detail required
- Outstanding organizational skills with ability to multi-task and prioritize
- Prior experience in cell/gene therapy is preferred
- Experience in IND, IMPD, BLA, and MAA filings is preferred
Benefits
- 401(k) Plan
- Paid Vacation
- Paid Holidays
- Paid Leaves
- Medical Insurance
- Prescription Drug Coverage
- Dental Insurance
- Vision Coverage
- Short-Term Incentive Bonus
- Equity-Based Long-Term Incentive
Company overview
AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.