Senior Manager, Regulatory Affairs – US Lead

AstraZeneca

. Lead, plan, prepare, and deliver regulatory strategies and activities for assigned products and projects in the US .

Posted 9/29/2026full-timeUnited StatesSenior💰 $135,625 - $203,437 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and implementing US regulatory strategies, managing regulatory submissions, and providing strategic regulatory advice for global product development. Strong ability to collaborate with cross-functional teams and lead multiple projects in a time-sensitive environment.

Highest-signal resume keywords

Regulatory Strategy DevelopmentUS Regulatory SubmissionsCross-Functional CollaborationRegulatory ComplianceLeadership in Regulatory Affairs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ExperienceIND SubmissionsBLA/NDA SubmissionsOrphan Drug DesignationPediatric SubmissionsRisk AssessmentGxP UnderstandingRegulatory DocumentationStrategic Regulatory AdviceProject Management

Soft Skills

Interpersonal SkillsWritten CommunicationVerbal CommunicationPresentation SkillsRelationship Building

Tools & Technologies

Microsoft 365PowerPointVeeva

Industry Keywords

Pharmaceutical IndustryRegulatory AuthorityFDAGlobal Regulatory LeadEmerging Regulations

About the role

Key responsibilities & impact

Lead, plan, prepare, and deliver regulatory strategies and activities for assigned products and projects in the US
Develop and implement US regulatory strategies and provide regulatory advice to cross-functional strategies and deliverables
Manage and execute US regulatory submissions, including INDs, BLAs/NDAs, orphan drug designation applications, and pediatric submissions
Collaborate with Regulatory functions and cross-functional teams to deliver business objectives
Represent Alexion as point of contact with the US FDA and other external partners
Plan and manage regulatory authority meetings
Oversee operational activities related to regulatory authorizations
Support the Global Regulatory Lead in internal governance and advisory bodies
Develop and manage select regulatory processes and procedures
Support inspections and audits
Provide regulatory input to Commercial, Medical, and other Enterprise functions
Apply current regulatory requirements and trends within the assigned jurisdiction and focus area
Demonstrate leadership, ethics, and visibility within the Enterprise, with Health Authorities, and with external partners

Requirements

What you’ll need

6+ years of relevant Regulatory experience in the pharmaceutical industry
Experience in US regional regulatory strategies
Bachelor’s degree in life science required
Experience providing strategic regulatory advice for global product development through pre-approval and marketed assets
Ability to 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, including Senior Management
Strong interpersonal, written/verbal communication, and presentation skills
Consistent track record practicing sound judgment in risk assessment
Familiarity with new and emerging regulations and guidances
Understanding of GxPs and how to interpret regulatory information
Excellent use of Microsoft 365 (Office) tools, ideally including PowerPoint
Experience working in a regulatory documentation system such as Veeva
Proficient in English in the corporate setting

Benefits

Comp & perks

Short-term incentive bonus eligibility
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 and special-needs accommodation