Manager, Regulatory Quality, Vaccines

Pfizer

Manager, Regulatory Quality, Vaccines at Pfizer ensuring compliance and quality in vaccine development. Collaborating with cross-functional teams for regulatory deliverables and project execution.

Posted 7/1/2026full-timeRemote • New York • 🇺🇸 United StatesMid-LevelSenior💰 $88,500 - $147,500 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support projects of all levels of complexity (task-related) and take joint accountability for deliverables, or lead less complex projects/workstreams within the department
Partner closely with cross-functional stakeholders to drive execution of deliverables
Ensure project compliance with global regulatory standards by effectively contributing and influencing team decisions
Ensure regulatory deliverables are completed on time, in compliance with current regulatory guidance, and in full submission-ready format
Performs submission-ready quality review
Ensures documents align with current regulatory guidance and internal standards, confirming accuracy, consistency, completeness, and submission-ready formatting
Independently execute assigned tasks and deliverables, making well-defined, data-informed decisions in conjunction with direct line manager or more senior colleagues
Explore and propose ideas for process improvements within the confines of existing SOPs and guidance documents, raising new ideas for risk assessment
Foster a culture of innovation by developing scientific activities that support strategic goals
Identifies and addresses interpersonal or process conflicts within the immediate team, focusing on quick, practical solutions and escalating when necessary
Apply problem-solving skills to advance project development while maintaining high regulatory compliance

Requirements

What you’ll need

BA/BS with at least 4 years of experience, an MBA/MS with at least 2 years of experience
Extensive knowledge of regulatory and quality assurance in the pharmaceutical or vaccine industry
Strong understanding of global regulatory requirements and guidelines
Proven track record in project management within a regulatory or scientific setting
Experience in reviewing regulatory documentation
Ability to analyze and interpret scientific data to support regulatory submissions
Proficient in risk assessment and mitigation strategies related to vaccine development
Familiarity with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP)
Excellent organizational skills and attention to detail
Proficiency with document authoring and review tools (e.g., Microsoft Word advanced features) and regulated document management systems

Benefits

Comp & perks

health benefits to include medical, prescription drug, dental and vision coverage
401(k) plan with Pfizer Matching Contributions
additional Pfizer Retirement Savings Contribution
paid vacation
holiday and personal days
paid caregiver/parental and medical leave
participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of base salary

ATS Keywords

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Hard Skills & Tools

Regulatory Documentation ReviewProject ManagementRisk Mitigation StrategiesData AnalysisSubmission-Ready Quality Review

Soft Skills

Organizational SkillsProblem-SolvingInterpersonal Conflict ResolutionAttention to DetailCollaboration