Director, Regulatory Affairs – US Lead

AstraZeneca

. Develop, implement, and maintain regulatory strategies for assigned projects, products, and jurisdictions .

Posted 9/29/2026full-timeUnited StatesSenior💰 $186,233 - $279,349 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in developing and implementing regulatory strategies within the pharmaceutical industry, with a strong focus on US regulatory requirements and drug development processes. Proven ability to lead cross-functional teams and manage complex regulatory submissions while ensuring compliance with GxPs and emerging regulations.

Highest-signal resume keywords

Regulatory Strategy DevelopmentUS Regulatory ExperienceDrug Development KnowledgeRegulatory Documentation Systems (Veeva)Interpersonal Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyDrug DevelopmentRisk AssessmentRegulatory ComplianceProject ManagementRegulatory SubmissionsGxP KnowledgeRegulatory Guidance InterpretationStrategic Regulatory AdviceBriefing Package Development

Soft Skills

Interpersonal SkillsWritten CommunicationVerbal CommunicationPresentation SkillsCollaboration

Tools & Technologies

Microsoft 365Microsoft PowerPointRegulatory Documentation Systems

Industry Keywords

Pharmaceutical IndustryFDAEU RegulationsCanada RegulationsPre-Approval AssetsMarketed AssetsGlobal Regulatory TeamAgency MeetingsCross-Functional CollaborationLife Science Degree

About the role

Key responsibilities & impact

Develop, implement, and maintain regulatory strategies for assigned projects, products, and jurisdictions
Serve as US Strategy Lead on assigned programs
Act as submission sub-team lead for US submissions and core member of the Global Regulatory Team
Represent Alexion as point of contact with the FDA
Lead and manage Agency meetings
Support and coordinate briefing package development
Develop and direct regulatory strategies for assigned projects and products
Collaborate with management, the Global Regulatory Lead, and cross-functional colleagues across commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, and portfolio management
Monitor new regulatory requirements and guidance documents and advise product teams on business or program impacts
Ensure exemplary behavior, ethics, and transparency within the company and with regulatory agencies

Requirements

What you’ll need

8+ years of relevant Regulatory experience in the pharmaceutical industry
Experience in US regional regulatory strategies
Bachelor's degree in life science required
Strong knowledge of drug development and the regulatory environment
Experience providing strategic regulatory advice in relevant jurisdictions, such as the US, EU, or Canada, across pre-approval and marketed assets
Ability to manage complex issues and lead multiple projects simultaneously in a time-sensitive fashion
Ability to build intra- and inter-team relationships and collaborate in a global team environment at all organizational levels
Strong interpersonal, written/verbal communication, and presentation skills
Proven track record practicing sound judgment in risk assessment
Knowledge of new and emerging regulations and guidances
Understanding of GxPs and how to interpret regulatory information
Excellent use of Microsoft 365/Office tools, ideally with strong PowerPoint skills
Experience working in a regulatory documentation system such as Veeva
Proficient in English in the corporate setting

Benefits

Comp & perks

Short-term incentive bonuses
Equity-based awards for salaried roles
Qualified retirement programs
Paid time off, including vacation, holiday, and leaves
Health coverage
Dental coverage
Vision coverage
Tailored development opportunities
Disability or special-needs accommodation