Manager, Regulatory Quality, Vaccines
Pfizer
Role Responsibilities
- Support and oversee multiple moderate-complexity projects/workstreams; take joint accountability for deliverables or lead less complex work.
- Partner with cross-functional stakeholders to drive execution of regulatory deliverables.
- Ensure compliance with global regulatory standards and current regulatory guidance.
- Complete regulatory deliverables on time in full, submission-ready format.
- Perform submission-ready quality review.
- Ensure documents are accurate, consistent, complete, and formatted to internal/regulatory standards.
- Independently execute assigned tasks and make data-informed decisions with line manager/senior guidance.
- Propose process improvements within existing SOPs/guidance and raise risks for assessment.
- Develop scientific activities supporting strategic goals.
- Identify and resolve team interpersonal/process conflicts; escalate when needed.
- Apply problem-solving to advance projects while maintaining high regulatory compliance.
Basic Qualifications
- BA/BS + 4+ years experience OR MBA/MS + 2+ years.
- Extensive regulatory/quality assurance knowledge in pharma/vaccines.
- Strong understanding of global regulatory requirements; project management experience.
- Experience reviewing regulatory documentation.
- Ability to analyze/interpret scientific data for submissions.
- Risk assessment/mitigation experience for vaccine development.
- Familiarity with GMP and GCP.
- Strong organization/attention to detail; document authoring/review tools and regulated document management systems.
Preferred Qualifications
- Experience leading cross-functional teams.
- Strong communication/presentation; stakeholder relationship building.
- Demonstrated leadership/people management; critical thinking/problem-solving.
- Adaptability/resilience; negotiation and conflict resolution.
Additional
- Available for overtime as needed; Work Location: Remote.
- Salary: $88,500β$147,500 base; bonus target 10% (Pfizer Global Performance Plan). Benefits include 401(k) match, paid time off, caregiver/parental and medical leave, and medical/dental/vision.
- Relocation assistance may be available (eligibility/business needs).