Manager, Regulatory Program Management & Submission Strategy (Oncology)
Pfizer, San Diego, CA, United States
Job Summary
The Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive regulatory program management support that ensures alignment with and execution of Pfizer Oncology’s regulatory strategies and submission deliverables. This position is accountable for coordination and prioritization of regulatory activities, facilitation of decision‑making processes, and oversight of information flow to ensure adherence to regulatory timelines and commitments. The Manager, RPMSS plays a critical role in partnering with regulatory strategists to advance regulatory and submission activities for assigned programs within the oncology portfolio.
Job Responsibilities
Develop and manage submission timelines and milestones, identify efficiencies, and proactively follow up to ensure on‑time delivery.
Contribute to design and implementation of processes that enhance workflow efficiency and provide guidance on best practices.
Organize and manage GRST, Submission Team, MCI and other leadership pre‑alignment meetings, including scheduling, agenda preparation, material distribution, minute‑taking, action item follow‑up, and appropriate storage of all documentation.
Proactively identify and resolve project issues to meet productivity, quality, and organizational goals.
Lead or co‑lead projects, managing time and resources effectively, considering impact on team members.
Develop and maintain templates, dashboards, team rosters, document reviewer lists, SharePoint/Teams sites, and action trackers.
Independently prepare comprehensive status reports, timelines, tables, graphs, correspondence, and presentations for internal and external stakeholders.
Track and analyze metrics to support business insights.
Assist with onboarding of new team members and provide training and guidance for new project system users.
Qualifications / Skills
Education
Bachelor’s Degree with 4+ years of experience or Master’s Degree with 2+ years of experience
Experience
2–4+ years of experience in the biopharmaceutical industry – understanding of oncology preferred
Experienced in managing day‑to‑day planning and project management to enable execution of complex strategies
Experienced in communicating and interacting with senior executive stakeholders
Experienced in managing multiple, competing tasks simultaneously
Demonstrated ability to work collaboratively with diverse teams and manage a team of cross‑functional colleagues
Demonstrated understanding of systems and structures, and ability to implement efficient processes
Attributes
Demonstrate resourcefulness with proven ability to anticipate needs, prioritize responsibilities, and manage multiple priorities with tight timelines
Strong project management skills with demonstrated attention to detail
Possess a high energy level, sense of urgency, creativity, decisiveness, and ability to work hard under pressure
Demonstrated strong self‑starter, independent, proactive, solutions‑oriented, and self‑motivated
Ability to exhibit sound judgment in handling confidential information
Ability to work well both in a team environment and operate independently with limited direct supervision
Possess excellent communication skills and respond with professionalism in verbal and written communications with all levels of the organization
Proficiency in MS Word, Excel, PowerPoint, and Outlook are essential; understanding of MS Project is preferred
Know and model Pfizer Values and Pfizer Core Competencies
Excellent collaborator and ability to navigate a fast‑paced, highly matrixed environment
Work Location Assignment
Hybrid – must be onsite an average of 2.5 days per week.
Compensation & Benefits
The annual base salary ranges from $99,200.00 to $165,400.00. Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and share‑based long‑term incentive program. Benefits include a 401(k) plan with Pfizer matching contributions, retirement savings contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental and vision coverage. Additional information available on Pfizer’s career site.
Relocation Assistance
May be available based on business needs and eligibility.
Work Visa Sponsorship
U.S. work visa sponsorship (e.g., TN, O‑1, H‑1B) 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.
Accessibility
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. For assistance ... contact disabilityrecruitment@pfizer.com.
#J-18808-Ljbffr
The Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive regulatory program management support that ensures alignment with and execution of Pfizer Oncology’s regulatory strategies and submission deliverables. This position is accountable for coordination and prioritization of regulatory activities, facilitation of decision‑making processes, and oversight of information flow to ensure adherence to regulatory timelines and commitments. The Manager, RPMSS plays a critical role in partnering with regulatory strategists to advance regulatory and submission activities for assigned programs within the oncology portfolio.
Job Responsibilities
Develop and manage submission timelines and milestones, identify efficiencies, and proactively follow up to ensure on‑time delivery.
Contribute to design and implementation of processes that enhance workflow efficiency and provide guidance on best practices.
Organize and manage GRST, Submission Team, MCI and other leadership pre‑alignment meetings, including scheduling, agenda preparation, material distribution, minute‑taking, action item follow‑up, and appropriate storage of all documentation.
Proactively identify and resolve project issues to meet productivity, quality, and organizational goals.
Lead or co‑lead projects, managing time and resources effectively, considering impact on team members.
Develop and maintain templates, dashboards, team rosters, document reviewer lists, SharePoint/Teams sites, and action trackers.
Independently prepare comprehensive status reports, timelines, tables, graphs, correspondence, and presentations for internal and external stakeholders.
Track and analyze metrics to support business insights.
Assist with onboarding of new team members and provide training and guidance for new project system users.
Qualifications / Skills
Education
Bachelor’s Degree with 4+ years of experience or Master’s Degree with 2+ years of experience
Experience
2–4+ years of experience in the biopharmaceutical industry – understanding of oncology preferred
Experienced in managing day‑to‑day planning and project management to enable execution of complex strategies
Experienced in communicating and interacting with senior executive stakeholders
Experienced in managing multiple, competing tasks simultaneously
Demonstrated ability to work collaboratively with diverse teams and manage a team of cross‑functional colleagues
Demonstrated understanding of systems and structures, and ability to implement efficient processes
Attributes
Demonstrate resourcefulness with proven ability to anticipate needs, prioritize responsibilities, and manage multiple priorities with tight timelines
Strong project management skills with demonstrated attention to detail
Possess a high energy level, sense of urgency, creativity, decisiveness, and ability to work hard under pressure
Demonstrated strong self‑starter, independent, proactive, solutions‑oriented, and self‑motivated
Ability to exhibit sound judgment in handling confidential information
Ability to work well both in a team environment and operate independently with limited direct supervision
Possess excellent communication skills and respond with professionalism in verbal and written communications with all levels of the organization
Proficiency in MS Word, Excel, PowerPoint, and Outlook are essential; understanding of MS Project is preferred
Know and model Pfizer Values and Pfizer Core Competencies
Excellent collaborator and ability to navigate a fast‑paced, highly matrixed environment
Work Location Assignment
Hybrid – must be onsite an average of 2.5 days per week.
Compensation & Benefits
The annual base salary ranges from $99,200.00 to $165,400.00. Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and share‑based long‑term incentive program. Benefits include a 401(k) plan with Pfizer matching contributions, retirement savings contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental and vision coverage. Additional information available on Pfizer’s career site.
Relocation Assistance
May be available based on business needs and eligibility.
Work Visa Sponsorship
U.S. work visa sponsorship (e.g., TN, O‑1, H‑1B) 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.
Accessibility
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. For assistance ... contact disabilityrecruitment@pfizer.com.
#J-18808-Ljbffr