Senior associate regulatory strategy

Use Your Power for Purpose

At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your role will be instrumental in ensuring that our life-saving treatments reach those in need, ultimately contributing to the betterment of global health.

ROLE SUMMARY:

In this role, you will:

• Provide strategic product direction and interact with regulatory agencies to expedite the approval of pending registrations
• Serve as the regulatory liaison throughout the product lifecycle, representing regulatory interests to marketing, research project teams, and government agencies
• Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports
• Guide operational teams in managing projects, preparing resource forecasts, and identifying areas for improvement in products, processes, or services
• Lead or co-lead moderately complex projects, managing time and resources effectively, and provide guidance to teams
• Apply skills and discipline knowledge to contribute to departmental work and make decisions to resolve moderately complex problems
• Work independently, receive instruction on unusual or complex problems, and determine objectives of assignments
• Review own work, seek directional review from others, and mentor colleagues by reviewing their work
• Collaborate with Global Chemistry Manufacturing and Controls and other key stakeholders to ensure well-defined and executed filing strategies for initial registrations and lifecycle submissions
• Enhance efficiencies in regulatory submissions and processes by working across the organization with various stakeholders
  
  

BASIC QUALIFICATIONS:

• Bachelors degree with at least 2 years of experience
• Effective delivery in a complex matrix environment
• Regulatory experience, including knowledge of New Drug Application (NDA) and Investigational New Drug (IND) submission processes
• In-depth understanding of national and regional regulatory legislation and guidelines
• Proficiency in pharmaceutical analytics technology, pharmacology, toxicology, and medicine
• Leadership qualities and management skills
• Strong written and verbal communication and interpersonal skills
  
  

PREFERRED QUALIFICATIONS:

• Master's degree is highly desirable, coupled with relevant experience in the pharmaceutical industry
• Background in pharmaceuticals, providing a solid foundation for the role
• Experience in the pharmaceutical sector, enhancing the ability to contribute effectively
• Advanced education and practical experience, ensuring a well-rounded and capable professional
  
  

ADDITIONAL DETAILS:

• Last date to apply is November 13, 2025
  
  

The annual base salary for this position ranges from $77,100.00 to $128,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. 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

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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.

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Regulatory Affairs