Why Patients Need You

　　Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

　　What You Will Achieve

　　This position is responsible for acting as a Site Compliance Network Member interface, in order to facilitate changes with regulatory impact. The role interfaces heavily with site personnel, as well as colleagues in Pfizer Center and individual markets, in order to assess the impact of deviations and changes, initiate regulatory changes, and provide site information for market renewals and queries. The role exists with a focus on products manufactured in Rocky Mount, having responsibility for the support of those products, globally. This position acts as the primary conduit for communication with Pfizer Center Global CMC, both using formal processes and in informal discussions, often functioning with a high degree of independence. The role is often engaged in site projects, acting as the primary regulatory interface for project execution.

　　How You Will Achieve It

　　Initiate/Respond to regulatory changes, using the corporate regulatory change control system.Independently conduct assessments of site deviations and change controls, for registration impact.Support license renewals in global markets, through the development of support strategies, and the preparation and submission of site documents to Pfizer colleagues, globally.Develop and provide site responses to queries received from global Health Authorities.Provide significant peer leadership to colleagues throughout the local site, in order to develop responses to regulatory requests.Assure that all requested information is provided within necessary timelines.Develop strategies and lead outcomes for regulatory changes, in partnership with a variety of functions, both locally and globally.Ensure communication of regulatory approvals to appropriate site personnel.

　　Qualifications

　　Must-Have

　　Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experienceOR an associates degree with 8 years of experienceOR a bachelors with at least 5 years of experienceOR Masters Degree with more than 3 years of experienceOR a PhD with 0+ years of experience.Demonstrated ability in developing scientific reasoning and problem solving with minimal coaching, as well as excellent written and oral communication skills. Ability to engage colleagues globally to resolve regulatory issues, recognizing the organizational and cultural differences that may exist between partners around the world.Excellent negotiation skills and ability to frequently resolve issues with a focus on regulatory compliance. Demonstrated skill in developing solutions with a flexible approach to the development of options.

　　Nice-to-Have

　　Experience with industry-related regulatory changes

　　PHYSICAL/MENTAL REQUIREMENTS

　　Office environment, primarily.

　　Other Information

　　Last date to apply: 12/20/23Relocation support available

　　The annual base salary for this position ranges from $90,800.00 to $151,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer 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 vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

　　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.

　　Quality Assurance and Control