Pfizer CMC Regulatory Change Management Manager in Sholinganallur, India
This position reports to the CMC Regulatory Change Management Senior Manager and is responsible for driving efficient submission execution while assuring product compliance through timely and accurate maintenance of CMC product knowledge in CMC Regulatory and PGS quality systems. Main activities for this role include submission strategy responsibilities, systems and regulatory change management compliance, submission document maintenance, and related CMC publishing support. Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content, and an integrated change management process is essential both for providing a comprehensive view of, and supporting compliance with the CMC registered details of all products in all markets. This role is part of a team of technical aligned CMC experts connected directly to CMC Product Strategists in conjunction with CMC Advisory Office, WSR-I, WRO, and PGS colleagues who are accountable for expeditious and efficient submission execution and CMC product registration/application compliance through timely and accurate maintenance of CMC content (particularly Module 3 Regulatory Commitments).
In direct collaboration with CMC Product Strategists, manage CMC regulatory submission preparation, planning, prioritization and content management in relevant regulatory systems in accordance with regional/local submission requirements and Pfizer standards for all innovative investigational and commercial product registrations and applications.
Apply knowledge of CMC products and systems to provide both general and scenario-specific change management oversight and submission authoring guidance across all levels of GCMC to insure a submission structure which balances core content authoring with country specific needs and continued maintenance of all the manufacturing license components.
Partner across GCMC functional lines, including the CMC Conformance Office to evaluate and refine the CMC Change Management and Compliance process to identify inconsistencies, gaps, and procedure/training needs.
Proactively assess CMC product compliance status to identify risks and partner with CMC strategists/relevant stakeholders to mitigate.
Utilize procedure, system, and practical knowledge and expertise to assist in review and/or update of procedures, processes and training to both properly ensure user understanding and promote conformance.
Product Compliance and Submission Strategy/Planning responsibilities include:
Maintain contemporary compliance of product registrations/applications, in particular as an interface with WSR-I/PCO colleagues, to ensure submission delivery and compliance and develop submission planning strategies.
Collaborate with CMC Project Team Leaders, CMC Product Strategists/Authors, CMC Advisory Office, PGS and WRO to share knowledge, align expectations and establish action plans to prepare submission documentation for publishing.
Creation of SPA Project and Submission Plans and management/maintenance of planned handover and target dispatch dates in relevant planning systems via communication with strategy, and downstream partners.
Collaborate with CMC Product Strategists to prioritize submissions based on product impact, submission criticality and supply needs
Perform critical quality evaluation of CTD (esp. module 3) submission structures to ensure consistency, logic, suitability and compliance with regional requirements.
Utilize DBTs and RRM to assess requirements across multiple markets to reconcile differences to facilitate post approval authoring.
Utilize and apply technical expertise to identify and execute solutions that contribute to efficiency in departmental business objectives.
Creation and Maintenance of PDM DocSets and management of CMC content in GDMS.
Document and Market level status & date updates
For Innovative portfolio, log submission/approval evidence, dates and submission component status in PDM to ensure CMC Product Strategists and PGS have current, accurate view of health authority approval status
PDN Node creation & market metadata management
Prospective and/or retrospective PDM content evaluation, loading and linking
Assess submission document variables across markets per change and ensure appropriate virtual document structure is built to enable efficient document usage across markets and maintenance of components in GDMS in support of all product submissions and integrated change management activities.
Partner with CMC strategists to design and maintain Global CMC submission templates with focus on core dossier approach and in accordance with current global regulatory requirements
Submission ready review/formatting and approval of GDMS submission components.
Serve as submission compliance liaison to Worldwide Regulatory Operations, Pfizer Country Offices and/or Alliance Partners for eCTD submissions and MRP/DCP Submissions to ensure deliverables are met in line with CMC dossier management best practices.
Manage submission workload in the Submission Planning Application (SPA) by utilizing appropriate queries, dashboards, reports and workflows.
Assistance with market requirement assessments (RRM/DBT searches and reporting)
In conjunction with the CMC Strategists, engage directly with WSR-I regions on detailed submission strategy, planning and execution
In partnership with GCMC Advisory Office, maintain Regulatory Requirements Manager (RRM)
Involvement in Submission Kick off Meetings for PIH initial commercial submissions, initial INDs or other major submission projects to trigger and facilitate appropriate CMC planning and compliance activities.
Main and Specific Submission Execution responsibilities include:
Compile CMC submission components in alignment with regional requirements and endorsed submission strategies
QC of final submission package against Regulatory Requirements Manager (RRM) and/or Dossier Build Templates (DBT) prior to dispatch to partner, as applicable, to ensure all necessary M3 components and Ancillary documents are present. (Initial and Post Approval)
Dispatch CMC portions of regulatory submissions to applicable partner lines via appropriate systems/mechanisms
Bachelors level education in pharmaceutical-science or related discipline.
6+ years within the pharmaceutical industry, ideally within Pharmaceutical Sciences, GMP Manufacturing, and/or Regulatory CMC.
Expert skills in document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools
Experience with CMC change management processes/systems and CMC CTD content is essential.
Demonstrated breadth of conformance knowledge and requirements is required along with several well-defined areas of particular expertise. Strong understanding of identifying and mitigating compliance risks through proper management of CMC product content.
For internal candidates, solid knowledge of supported tools, applications, processes and associated data; detailed knowledge of database logical structures is essential as part of CMC content maintenance
Able to build strong global and local networks across functions, lines and zones.
Pharmaceutical industry, specifically Chemistry, Manufacturing and Controls regulatory or quality experience required.
Aptitude for customer service, facilitation, and conflict resolution, approaching all situations with enthusiasm and integrity, despite demanding workload, technical barriers and changing deadlines and requirements.
Ability to work independently is mandatory. Position receives minimal supervision and guidance and works independently on most projects.
Require experience with CMC regulatory submissi
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.