Senior Manager, Regulatory Affairs

AstraZeneca

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

Posted 11/3/2026full-timeUnited StatesSenior💰 $109,245 - $163,867 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 throughout the product lifecycle. Exhibits strong leadership and collaboration skills while maintaining compliance with regulatory requirements and trends.

Highest-signal resume keywords

Regulatory Strategy DevelopmentUS Regulatory Submissions ManagementCross-Functional CollaborationRegulatory Compliance ExpertiseLeadership and Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsINDsBLAsNDAsOrphan Drug DesignationPediatric SubmissionsRegulatory DocumentationRisk AssessmentGxP UnderstandingRegulatory Information Interpretation

Soft Skills

Interpersonal SkillsWritten CommunicationVerbal CommunicationPresentation SkillsJudgment

Tools & Technologies

Microsoft 365PowerPointVeeva

Industry Keywords

Pharmaceutical IndustryRegulatory AffairsFDAGlobal Product DevelopmentEmerging Regulations

About the role

Key responsibilities & impact

Lead, plan, prepare, and deliver regulatory strategies and activities for assigned products and projects
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
Serve as Alexion’s point of contact with the US FDA and other relevant 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 and other internal activities
Develop and manage selected Regulatory processes and procedures
Support inspections and audits
Provide regulatory input to business-relevant deliverables with Commercial, Medical, and other Enterprise functions
Apply current regulatory requirements and trends within the assigned jurisdiction and regulatory focus area
Demonstrate leadership, ethics, and visibility within the Enterprise and with health authorities and external partners

Requirements

What you’ll need

3+ years of relevant Regulatory experience in the pharmaceutical industry
Experience in US regional regulatory strategies
Bachelor’s degree required
Experience providing strategic regulatory advice in relevant regulatory jurisdictions for global product development through pre-approval and marketed stages
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 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 in relevant areas
Solid understanding of where to seek 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
Inclusive environment and equal employment opportunities
Disability or special-needs accommodation