Senior Associate, Global Regulatory Strategy for Oncology
PfizerAbout the role
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
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
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