Manager, Global Regulatory Strategy

AstraZeneca

Manager of Global Regulatory Strategy developing US regulatory strategy for complex pharmaceutical products. Ensuring effective regulatory planning and high-quality deliverables with cross-functional collaboration.

Posted 7/23/2026full-timeGaithersburg • Maryland, Massachusetts • 🇺🇸 United StatesMid-LevelSenior💰 $109,244 - $163,867 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in developing and implementing regulatory strategies for pharmaceutical products, with a strong focus on drug development, regulatory policy, and compliance with GMPs, GLPs, and GCPs. Proven ability to provide strategic regulatory advice and manage complex projects in a collaborative global environment.

Highest-signal resume keywords

Regulatory Strategy DevelopmentPharmaceutical Industry Regulatory AffairsDrug Development KnowledgeGMPs, GLPs, and GCPs UnderstandingStrategic Regulatory Advice

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submissions ManagementLocal Marketing Authorization ApplicationsRegulatory Policy KnowledgeProject CoordinationComplex Issue Management

Soft Skills

Interpersonal SkillsWritten CommunicationVerbal CommunicationCollaborationRelationship Building

Certifications & Qualifications

Bachelor's Degree in Scientific or Clinical Field

Industry Keywords

Regulatory AffairsPharmaceutical IndustryRegulatory RequirementsGuidance DocumentsEffective Ways of Working

About the role

Key responsibilities & impact

Develop and implement US regulatory strategy for unique products
Provide strategic regulatory input and execution support to assigned programs
Coordinate regulatory submissions and manage local marketing authorization applications
Monitor the development of new regulatory requirements and guidance documents
Contribute to effective ways of working and consistent regulatory practices

Requirements

What you’ll need

5+ years of experience in pharmaceutical industry regulatory affairs
Bachelor's Degree, preference to a scientific or a clinical degree
Strong knowledge of drug development and regulatory policy
Experience providing strategic regulatory advice for product development
Ability to manage complex issues and coordinate multiple projects
Ability to build intra-team relationships and collaborate in a global environment
Strong interpersonal and written/verbal communication skills
Understanding of GMPs, GLPs and GCPs

Benefits

Comp & perks

Health, dental, and vision coverage
Paid time off (i.e., vacation, holiday, and leaves)
Qualified retirement programs
Eligibility for short-term incentive bonuses
Equity-based awards for salaried roles