Manager, Scientific Regulatory Strategy & Submissions
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Job Location:
La Jolla, CA - USA
Monthly Salary:
$ 96300 - 160500
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
Key Responsibilities:
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 Pfizers regulatory systems and standards.
Competencies & Behaviors:
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
The annual base salary for this position ranges from $96300.00 to $160500.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 (). 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
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 providers 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.
Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Required Experience:
Manager
Key Skills
- Marketing
- Data Visualization
- Tableau
- Customer Segmentation
- Microsoft Powerpoint
- Investment Banking
- Strategic Planning
- Financial Modeling
- Customer relationship management
- Management Consulting
- Google Suite
- Analytics
About Company
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