AstraZeneca · 17 hours ago
Associate Director, Regulatory Affairs CMC (Cell & Gene Therapy)
Gaithersburg, MD
Full-time
Hybrid
Lead/Staff, Director/Executive
$135K/yr - $203K/yr
8+ years expAstraZeneca is a leading biopharmaceutical company dedicated to pioneering the future of healthcare. The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies will support the development and implementation of CMC regulatory strategies for innovative therapies, collaborating with cross-functional teams to ensure high-quality regulatory submissions.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
2026-01-23
Pharma Letter
2026-01-22
Company data provided by crunchbase