WHY PATIENTS NEED YOU
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve.
WHAT YOU WILL ACHIEVE
In this role, you will:
Works independently to manage key site changes with regulatory impact from initiation through submission to implementation and manages product holds for pending market activities.
Exercises own judgement leveraging knowledge and experience with minimal assistance from Management.
Provides peer leadership to mentor and develop other colleagues.
Supports license renewals in global markets, through the development of support strategies, and the preparation and submission of site documents to Pfizer colleagues globally with emphasis on supply equity.
Develops and reviews site responses to queries received from global Health Authorities.
Ensures communication of regulatory approvals to appropriate site personnel and PC1 customers.
Manages communication between PC1 customers, site SMEs and Regulatory Affairs, works with Reg Affairs to resolve issues, holds meetings with strategists and PC1 customers to discuss open regulatory impact assessments for proposed changes.
Completes impact assessments for key site change requests to document potential for regulatory impact and manage implementation.
May complete the CNM and/or PC1 customer section of Annual Product Reviews.
Manages Pfizer support of PC1 US annual report process.
Upkeep and development of department SOPs, monitoring alignment with regulations and Pfizer Quality Standards.
QUALIFICATIONS
Must-Have
Applicant must have a bachelor's degree with at least 5+ years of experience; OR a master's degree with at least 3+ years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8+ years of experience; OR a high school diploma (or equivalent) and 10+ years of relevant experience.
Exceptional organizational and project management skills.
Demonstrated strength in analytical skills and meticulous attention to detail.
A solid understanding of the regulatory and audit frameworks pertinent to biopharmaceutical operations.
Proficiency in taking decisive action based on quality and compliance metrics and trends.
Capable of managing multiple complex projects with a strong sense of business acumen.
Excellent interpersonal effectiveness, coupled with superior written and verbal communication skills.
Nice-to-Have
Experience working in quality, compliance, and/or regulatory roles.
Pharmaceutical industry experience.
Demonstrated regulatory change management experience.
Strong project management capabilities.
Ability to adapt to changing priorities and manage multiple tasks simultaneously.
PHYSICAL/MENTAL REQUIREMENTS
Sitting, standing, walking, ability to perform mathematical calculations, and ability to perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Core business hours 8-5, occasional evening, weekend, and holiday work may be required.
No routine travel, occasional travel 0-10%
OTHER JOB DETAILS
Last Date to Apply for Job: March 27, 2026
Additional Location Information: US - KS - Remote
Eligible for Relocation Package – NO
Secondment 12 months
If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.
There will be no change to your current work location.
Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).
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.