Pfizer Oncology Research and Development Regulatory Portfolio Manager in San Diego, California
The Oncology Regulatory Portfolio Manager (RPM) shall provide project management of the nonclinical pharmacology (NCP) contributions to regulatory submissions across the oncology portfolio.
The RPM ensures that the contributions of Oncology Research & Development (ORD) scientific staff are of the appropriate quality and meet timelines established by the project team. The RPM will work closely with the ORU Regulatory Writer to build and ensure that content is developed in line with the internal regulatory strategy and Health Authority requirements. The RPM will also ensure all necessary quality controls have been observed in the generation of pharmacology reports and summaries to support a broad range of international regulatory requirements and that all supporting research summaries and study documentation meet Pfizer quality standards and policy.
The ORD Portfolio Manager will interface with Research Project Leads (RPLs), Regulatory Affairs, Nonclinical Pharmacology (NCP), Drug Safety, and Pharmacokinetics Dynamics & Metabolism (PDM) groups in order to manage updated timelines and deliverables for ORD programs.
The RPM will collaborate with the Alliance Manager(s), Business Development, and RPLs in establishing expectations for documents related to work performed externally for in licensed assets as well as appropriate quality reviews as it relates to regulatory submissions. On a project-by project basis, RPM will interface with external collaborators to coordinate report/submission content and quality requirements to meet Pfizer standards and policy. This will also include verifying collaborator source data is appropriately documented, secured, and accessible per Pfizer policy.
The RPM, in collaboration with the NCP Regulatory Submission Manager and Document Specialist, will ensure master calendars tracking regulatory submissions and all critical deliverables for ORD scientific teams are updated to reflect accurate Oncology Research Unit (ORU) portfolio timelines.
The RPM project manages the preparation and quality review of global regulatory documentation and ensures timely submission and quality compliance to meet business and agency milestones. The range of submission types include, but are not limited to, study reports (internal and external), INDs, CTAs, NDAs, MAAs, sNDAs, ODDs, IBs, labeling submissions, briefing documents, periodic reports including annual reports, and responses to agency queries. The RPM will also receive and manage the flow of all requests for ORU pharmacology queries as requested from international regulatory agencies.
The RPM will work closely with RPLs and regulatory writers to ensure that source documentation and Biobook records have been reviewed and published per Pfizer quality polices in support of ORD regulatory submissions. The RPM will perform in quality reviews as needed.
Track oncology portfolio deliverables and milestones through contacts with Research Project Leads (RPL), Regulatory Affairs, NCP, DSRD, PDM, etc.
Manage timelines and ensure delivery of documents for ORU NCP regulatory deliverables, including study reports (internal and external), IND, PreIND, BLA, NDA, MAA, CTA, Annual Reports, Orphan Drug Designation, Breakthrough Designation, queries, etc.
Build and deliver training programs, specific to the ORD, describing the regulatory process, quality review and documentation process, roles and responsibilities, and content requirements in alignment with Pfizer requirements for data integrity
Ensure quality compliance of electronic notebooks, study reports, and regulatory submissions according to Pfizer policies (SOPs), standards, and guidelines
Perform preliminary review of documentation provided to NCP Regulatory Submission Manager or Document Specialist.
Develop and determine creative solutions to cross-functional complex problems and ensure solutions are aligned with business strategies and have a positive impact on the business.
Interface with enabling partners (NCP, Business Technology, etc.) in developing solutions for maintaining ORD records and developing templates for use across partner lines
Actively engage with Pfizer Regulatory Operations and Submissions Management departments to contribute to an up-to-date knowledge and planning of standards.
Participate in cross-line process improvement projects to improve regulatory processes as needed.
Participate in Worldwide Research & Development (WRD) as ORD subject matter expert for initiatives related to submission-ready components (SRC), submission content and review requirements, document databases, tools, workflows, and documentation.
Provide expert opinion on realistic deadlines and level of effort required to process specific document types in advance of submission deadlines. Manage processes within ORD to ensure our regulatory contributions are made on time with high quality.
Interface with the NCP Submission Manager and Document Specialists who generate document templates and perform formatting.
For external (collaborator/vendor) reports, ensure that content and quality reviews have been performed against source data before use in a Pfizer regulatory submission. Includes verifying source data has been reviewed by RPL or authorized Pfizer individual and archived prior to report finalization.
Participate in records management compliance, ensuring appropriate communication across ORD for conformance to record retention policies and support department in accordance with corporate policies. Participate in record audits and other WRD inspections.
Advises and participates in the implementation of other compliance initiatives related to scientific integrity.
5+ years of experience working within a research regulatory environment
BS/MS in Scientific (i.e. Biology) related field.
Demonstrated knowledge of regulatory requirements from IND through BLA/NDA
Demonstrated knowledge/skills in project management
Ability to multitask and work under pressure in fast-paced environment
Training in accordance with Regulatory Training curriculum (SOP's, Policies)
Must have demonstrated expertise in Microsoft Office Suite (Word, Excel, Visio and Adobe)
Experience with electronic document management systems (e.g. GDMS)
Experience with MS Project
Knowledge of Pfizer submission processes a strong plus
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.