Use Your Power for Purpose
Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve
In this role, you will:
Be the Global Owner and Subject Matter Expert for the GMP/GDP Regulatory Surveillance Process. Responsible for overseeing and managing this business process across the organization, ensuring it is efficient, standardized, compliant and aligned to meet Pfizer's needs
As part of a global operational and strategic team, you will be responsible for monitoring emerging regulations, performing human in the loop review of AI generated triage results and co-author regulatory newsletter articles related to impactful regulatory content
Create and maintain systems for tracking and assessing regulation impact and workflows, creating visual management tools for leadership and internal team, as well as monitoring trends and signals and risk related to implementation of new board of health regulations.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience
Detailed knowledge of GMP/GDP Regulations and impact on Pfizer Quality Management Systems
Demonstrated diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers, develop and coach others, and create significant business impact
Strong project management, organization, and planning skills
Excellent written and verbal communication and collaboration skills
Finance awareness, with the ability to develop training budget estimates and justify costs effectively
Bonus Points If You Have (Preferred Requirements)
Experience working closely with a relevant regulator
Strong analytical and problem-solving skills
Ability to work in a fast-paced environment
The ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PHYSICAL/MENTAL REQUIREMENTS
N/A
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel for business meetings, workshops and potential Board of Health interactions
Must be located in time zones indicated (east coast US or Europe time zone).
NO RELOCATION SUPPORT AVAILABLE. *
Work Location Assignment: Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
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.