Manager, Regulatory Quality, Vaccines
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AI Summary
As Manager, Regulatory Quality, Vaccines at Pfizer, you will be at the forefront of innovation in vaccine development. Reporting to the Research & Development division, your work will directly contribute to improving patients' lives globally. Your efforts will ensure regulatory compliance and maintain the highest quality standards, ultimately leading to safer and more effective vaccines that protect individuals and communities.
In this role, you will support and oversee multiple projects and ongoing work activities of moderate complexity within the department. You will operate in a highly cross-functional environment, partnering closely with stakeholders across Research & Development and Vaccines, to ensure regulatory deliverables are completed on time, in compliance with current regulatory guidance, and in a full, submission-ready format.
ROLE RESPONSIBILITIES
- 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.
BASIC QUALIFICATIONS
- 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
PREFERRED QUALIFICATION
- Experience in leading cross-functional teams
- Strong problem-solving and critical-thinking skills.
- Effective communication and presentation skills.
- Ability to build and maintain strong relationships with internal and external stakeholders Experience supporting vaccine development programs and reviewing study reports.
- Demonstrated leadership and people management skills.
- Adaptability and resilience in a dynamic work environment.
- Strong negotiation and conflict resolution abilities.
PHYSICAL/MENTAL REQUIREMENTS
N/A
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Available to work overtime when necessary to meet urgent timelines.
Work Location Assignment: Remote
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
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