Manager, Regulatory Quality, Vaccines
Pfizer
Role Responsibilities:
- Support and oversee multiple department projects of moderate complexity; take joint accountability for deliverables or lead less complex workstreams.
- Partner cross-functionally to drive regulatory deliverable execution.
- Ensure compliance with global regulatory standards by contributing to team decisions.
- Complete regulatory deliverables on time in submission-ready format, including submission-ready quality review.
- Ensure documents are accurate, consistent, complete, and formatted to current regulatory guidance and internal standards.
- Independently execute assigned tasks and make data-informed decisions with line manager/senior input.
- Propose process improvements within SOPs/guidance and raise risks for assessment.
- Foster innovation through scientific activities aligned to strategic goals.
- Resolve team interpersonal/process conflicts and escalate when necessary.
- Apply problem-solving to advance projects while maintaining high regulatory compliance.
Basic Qualifications:
- BA/BS + 4+ years; MBA/MS + 2+ years.
- Extensive regulatory and quality assurance knowledge in pharmaceutical/vaccine industry.
- Strong understanding of global regulatory requirements.
- Project management track record in regulatory/scientific settings.
- Experience reviewing regulatory documentation.
- Ability to analyze/interpret scientific data for regulatory submissions.
- Proficient in risk assessment/mitigation for vaccine development.
- Familiarity with GMP and GCP.
- Excellent organizational skills and attention to detail.
- Proficiency with document authoring/review tools and regulated document management systems.
Preferred Qualifications:
- Experience leading cross-functional teams.
- Strong problem-solving/critical thinking, communication/presentation.
- Stakeholder relationship building; experience supporting vaccine development programs and reviewing study reports.
- Leadership/people management; adaptability/resilience; negotiation and conflict resolution.
Work: Available for overtime as needed; Remote.
Compensation/Benefits:
- Annual base salary: $88,500β$147,500; bonus target 10% of base via Global Performance Plan; 401(k) with matching, retirement contribution, paid time off, caregiver/parental and medical leave, and health benefits.