Manager, Regulatory Quality, Vaccines

Job Description:

  • 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:

  • 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:

  • 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
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