Manager, Regulatory Program Management & Submission Strategy (Oncology)

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

The Manager, RPMSS will provide comprehensive support to Pfizer Oncology’s Global Regulatory Strategy Teams (GRST) and Submission Teams, ensuring efficient execution in accordance with program strategy. Responsibilities include, but are not limited to:

• Develop and manage submission timelines and milestones using appropriate tools. Identify efficiencies to enable fast filings and convert submission timelines into clear, actionable tasks with proactive follow-up to ensure on-time delivery.

• Contribute to the design and implementation of processes that enhance workflow efficiency and provide guidance on best practices and procedures.

• 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, effectively managing time and resources for oneself, with consideration of 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 as needed 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, 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 team environment as well as operate independently

with limited direct supervision

· Possess excellent communication skills with an ability to 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.

The annual base salary for this position ranges from $99,200.00 to $165,400.00. 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.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Medical