ROLE SUMMARY:
The Manager, Scientific Regulatory Strategy & Submissions is a key member of the Scientific Regulatory Strategy (SRS) Oncology Research Unit (ORU) Portfolio & Scientific Operations team, responsible for leading and optimizing regulatory document management, process automation, and scientific content quality across the ORU portfolio. This role partners with cross-functional teams to ensure submission readiness, compliance, and the integration of innovative digital solutions. The SRS Manager will serve as a subject matter expert (SME) for regulatory document management systems, drive process improvements, and support the delivery of high-quality regulatory submissions.
Regulatory Systems Leadership
Serve as VEEVA VAULT regulatory management system SME for ORU, collaborating with SRS colleagues to define workflows.
Lead VEEVA RIM Content Plan build and execution for regulatory submissions.
Act as VEEVA Vault Quality SME, maintaining SOPs and quality documents for ORU.
Document Management & Regulatory Submissions
Lead ORU PoC for document migration from GDMS to VEEVA, ensuring accurate metadata transfer for large-scale migrations.
Oversee formatting and submission readiness of regulatory documents at all development stages.
Shepherd regulatory documents (IND, BLA/NDA/MAA, study reports, pediatric plans, Health Authority briefing docs) through review and approval to ensure compliance and submission readiness.
Conduct QC of scientific content against source documents
Monitor nonclinical pharmacology requests and alert SRS contacts to ensure annual updates (IND ARs, IB updates, ODD ARs) are completed.
Process Innovation & Automation
Lead the final build of ORU electronic laboratory notebook (ELN) templates in Signals Production.
Deliver ORU submission ready Study Reports from ELN templates, collaborating with Digital to develop document automation tools.
Lead ORU automation/GenAI efforts, focusing on testing and process improvements
Explore and develop additional AI workstreams to streamline the regulatory process using internal tools, collaborating with partner lines and departments to integrate AI into everyday practices.
Training & Stakeholder Engagement
Act as Pfizer Learning Academy Training point of contact for ORU training assignments and compliance.
Build cross-functional relationships to integrate various functions and drive project delivery.
Organize and facilitate meetings, prepare and distribute agendas, minutes, and materials, as needed.
BASIC QUALIFICATIONS:
Bachelors degree and a minimum of 4 years’ experience in regulatory operations, document management, or related field within biotech/pharma.
Strong understanding of regulatory submission processes and requirements.
Experience leading cross-functional teams and managing complex projects.
Proficiency with document management and project management tools (e.g., VEEVA, Signals, GDMS, MS project).
Excellent written and verbal communication skills.
Demonstrated ability to drive change and innovation in a matrix environment.
PREFERRED QUALIFICATIONS:
Masters degree.
Experience with AI-driven process automation.
Experience with large-scale document migration projects.
Familiarity with Pfizer’s regulatory systems and standards.
Demonstrates broad technical expertise and business acumen.
Leads and influences cross-functional teams to achieve results.
Champions innovation and continuous improvement.
Manages resources effectively and drives operational excellence.
Communicates clearly and fosters open collaboration.
Anticipates and manages change, adapting to evolving business needs.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
Potential meetings during non-standard hours and limited travel.
ADDITIONAL DETAILS:
Last date to apply is: November 18, 2025
Relocation assistance may be available based on business needs and/or eligibility.
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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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