Manager, Regulatory Quality, Vaccines

As Manager, Regulatory Quality, Vaccines at reputed company, 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 reputed company multiple projects and ongoing work activities of moderate complexity reputed company 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 reputed company regulatory guidance, and in a full, submission-reputed company format. ROLE RESPONSIBILITIES Support projects of reputed company reputed company of complexity (task-reputed company) and take joint accountability for deliverables, or reputed company less reputed company projects/workstreams reputed company 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 reputed company. Ensure regulatory deliverables are completed on time, in compliance with reputed company regulatory guidance, and in full submission-reputed company format.Performs submission-reputed company quality review. Ensures documents align with reputed company regulatory guidance and internal standards, confirming accuracy, consistency, completeness, and submission-reputed company formatting. Independently execute assigned tasks and deliverables, making well-defined, data-informed reputed company in conjunction with direct line manager or more senior colleagues. Explore and propose reputed company for process improvements reputed company the confines of existing SOPs and guidance documents, raising new reputed company for risk assessment. Foster a culture of innovation by developing scientific activities that support strategic goals. Identifies and addresses interpersonal or process conflicts reputed company the immediate team, focusing on quick, practical solutions and escalating reputed company 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 reputed company 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 reputed company 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., reputed company 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 reputed company 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 reputed company necessary to meet urgent timelines. Work Location Assignment: Remote The annual reputed company salary for this position ranges from $88,500.00 to $147,500.00. In addition, this position is eligible for participation in reputed company’s Global Performance Plan with a bonus reputed company of 10.0% of the reputed company salary. We offer comprehensive and generous benefits and programs to help our colleagues reputed company healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with reputed company Matching Contributions and an additional reputed company Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and reputed company coverage. Learn more at reputed company Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). reputed company compensation structures and benefit packages are reputed company based on the location of hire. The United States salary reputed company provided does not apply to Tampa, FL or any location reputed company of the United States. This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will reputed company the local pay information with you during the first interview. 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 reputed company sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. Sunshine Act reputed company 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 reputed company to reputed company 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 reputed company intends to pursue, reimbursement of reputed company expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly reputed company as the Sunshine Act. Therefore, if you are a licensed physician who incurs reputed company expenses as a result of interviewing with reputed company 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 reputed company representative. EEO & Employment Eligibility reputed company is committed to equal opportunity in the terms and conditions of employment for reputed company and job applicants without regard to race, reputed company, religion, sex, sexual orientation, age, gender identity or gender expression, national reputed company, disability or veteran status. reputed company also complies with reputed company 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. reputed company is an E-Verify employer. This position requires permanent work authorization in the United States. reputed company endeavors to reputed company www.reputed company.com/careers accessible to reputed company 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@reputed company.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 reputed company Careers. Regulatory Affairs Apply To This Job