AstraZeneca · 5 hours ago
Associate Regulatory Affairs Director
Gaithersburg, MD
Full-time
Onsite
Senior Level
$136K/yr - $203K/yr
5+ years expAstraZeneca is dedicated to advancing healthcare and creating an inclusive workplace. The Associate Regulatory Affairs Director will lead the planning, coordination, and execution of regulatory submissions, providing expertise and guidance to ensure compliance with health authority requirements.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Lead and/or contribute to the planning, preparation, and delivery of both simple and complex submissions throughout the product’s life cycle
Drive and lead delivery-focused teams, e.g., GRET (Global Regulatory Execution Team) on a product level or RSDT (Regulatory Submission Delivery Team) for major submissions (MAA/NDA)
Assume overall accountability for the planning, forecasting, and reporting, applying refined project and stakeholder management skills, ensuring optimized delivery of regulatory activities to time and quality
Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including: Submission delivery strategy of all dossiers and all application types per market and/or region
Review documents and provide regulatory input (e.g., response documents, high-level documents, study protocols, PSRs, etc.)
Analysis of regulatory procedures and special designations used during development, authorizations, and extension of the product
Identify regulatory risks, opportunities, and proactively develop mitigation strategies for operational regulatory activities, e.g., planned submissions (with input from all team members)
May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies
As a member of the Regulatory Affairs Manager community, the ARAD will be a recognized expert in the current regulatory environment. Understand the regulatory framework, including regional trends for various types of applications, procedures, and documents, in both small and large molecules with a particular focus on planning, delivery, and project management
Provide coaching, mentoring, and knowledge sharing within the RAM skill group
Contribute to process improvement
Qualification
Required
Bachelor's degree in science or a related field with 5+ years of regulatory experience within the biopharmaceutical industry or health authority
Thorough knowledge of drug development
Strong project management skills
Leadership skills, including experience leading multi-disciplinary project teams
Excellent written and verbal communication skills
Cultural awareness
Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
Ability to work independently and as part of a team
Influencing and stakeholder management skills
Ability to analyze problems and recommend actions
Continuous improvement and knowledge sharing focused
Preferred
Proficiency with common project management (e.g., MS Project) document management tools and Veeva Vault/ERV
Managed complex regulatory deliverables across projects/products
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program
Retirement contribution
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
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Essential Business
2026-01-24
2026-01-23
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