Technical and Regulatory Affairs Manager (Secondment - 12 Months)

WHY PATIENTS NEED YOU This 12 months secondment provides a broad development opportunity across technical services, regulatory lifecycle management, and regulatory strategy for Pfizer CentreOne Active Pharmaceutical Ingredients and intermediates. The secondee will provide customer focused technical and regulatory support, coordinate priority lifecycle activities, and contribute to consistent, compliant, and business enabling ways of working across PC1. The role combines hands on delivery with strategic coordination. It serves as a key interface among customers, external partners, PC1 Business Enablement, PC1 Operations, Quality, Manufacturing, Analytical, Supply, Business Development, and Regulatory Affairs. WHAT YOU WILL ACHIEVE Provide integrated technical, quality, and regulatory support across the lifecycle of assigned PC1 APIs and intermediates. Maintain regulatory compliance and support supply continuity through effective dossier management, change assessment, planning, and risk mitigation. Translate complex technical and regulatory information into clear, accurate, and customer ready responses. Strengthen standardization, knowledge management, and digital enablement across technical and regulatory processes. HOW YOU WILL ACHIEVE IT Technical Services and Customer Support Serve as a technical and regulatory point of contact for assigned customers, distributors, products, or markets. Coordinate responses to customer inquiries involving process descriptions, specifications, impurities, stability, analytical methods, technical declarations, and supporting documentation while maintaining confidentiality. Support quality agreement activities, customer audits, confidentiality agreements, regulatory document requests, and access to reference standards. Coordinate customer communications related to complaints, deviations, out of specification or out of trend results, supply events, and other technical matters, in partnership with the appropriate subject matter experts. Support the maintenance and curation of customer facing technical documentation and product files. Regulatory Lifecycle Management Support the maintenance of global regulatory dossiers for assigned APIs, including Drug Master Files, Active Substance Master Files, annual reports, amendments, variations, and related lifecycle records. Prepare, review, coordinate, or submit regulatory documentation in accordance with applicable procedures and regional requirements. Support customer regulatory submissions and requests, including questionnaires, Letters of Access, Certificates of Pharmaceutical Product, document legalization, and Certificates of Suitability where applicable. Monitor regulatory commitments, submission calendars, trackers, status logs, and dashboards to provide clear visibility of priorities, risks, and due dates. Support inspections and health authority interactions by coordinating timely, accurate, and consistent responses. Regulatory Strategy, Change, and Risk Assess the technical and regulatory impact of manufacturing, analytical, specification, process, and site changes across relevant markets and customers. Partner with cross functional experts to define regulatory strategies, customer communications, and mitigation actions that support compliance and supply continuity. Provide clear regulatory risk assessments, governance updates, and decision ready recommendations to PC1 leadership. Contribute to strategies that standardize submission content and external confidential technical responses across products and regions. Support market expansion requests and external partner engagement in collaboration with PC1 Operations and Business Enablement. Planning, Operations, and Capability Building Coordinate priorities and workload across assigned technical and regulatory activities, escalating risks and resource constraints when needed. Communicate both internally and externally with a confidentiality mindset related to both Pfizer and customer/partner interests. Drive continuous improvement in technical service and regulatory processes, including templates, knowledge management, metrics, dashboards, and automation. Complete a defined secondment capstone or improvement initiative that delivers a sustainable benefit to PC1. Key Deliverables During the Secondment Timely, accurate, and compliant delivery of assigned customer and regulatory commitments. Current and transparent trackers, calendars, and status reporting for assigned activities. Documented technical and regulatory assessments for relevant changes, risks, and decisions. At least one sustainable process, knowledge management, or digital improvement delivered through the secondment capstone. Effective knowledge transfer and a documented transition plan at the conclusion of the assignment. Knowledge, Skills, and Experience Working knowledge of pharmaceutical development, manufacturing, quality, or CMC regulatory requirements. Experience with APIs or intermediates is preferred. Experience supporting technical documentation, regulatory submissions, lifecycle activities, customer responses, or cross functional projects in a regulated environment. Ability to analyze complex information, identify risk, and develop clear, practical recommendations. Strong written and verbal communication skills, with the ability to adapt technical content for customers, partners, and leaders. Strong planning, attention to detail, stakeholder management, and influencing skills. Ability to manage multiple priorities with a quality first and customer focused mindset. Proficiency in Microsoft 365 tools. Experience with regulatory change systems, quality systems, document management platforms, dashboards, automation tools, SAP, or Salesforce is desirable. QUALIFICATIONS Must-Have Applicant must have a bachelor's degree with at least 5+ years of experience; OR a master's degree with at least 3+ years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8+ years of experience; OR a high school diploma (or equivalent) and 10+ years of relevant experience. Broader understanding of the PC1 API and intermediate business and the connection among customer needs, technical operations, regulatory strategy, and supply continuity. Practical experience in CMC regulatory lifecycle management, technical customer support, change assessment, risk management, and governance communication. Expanded cross functional network across PC1 Business Enablement, Operations, Quality, Manufacturing, Analytical, Supply, Business Development, and Regulatory Affairs. Opportunities to build strategic thinking, executive communication, prioritization, and digital process improvement capabilities. Assigned commitments are delivered accurately, on time, and in alignment with applicable procedures and quality expectations. Customers and internal stakeholders receive clear, consistent, and actionable technical and regulatory support. Risks, dependencies, and decisions are identified early and communicated with appropriate recommendations. The secondee demonstrates increased independence, sound judgment, and effective collaboration across the assignment. The capstone improvement is adopted, documented, and transitioned to a sustainable owner. This opportunity is suited to a colleague who is curious, collaborative, and motivated to broaden their experience across technical services and regulatory affairs. The successful candidate should be comfortable working across functions, learning new subject matter quickly, taking ownership of deliverables, and operating with appropriate judgment and escalation in a regulated environment while maintaining confidentiality OTHER JOB DETAILS Last Date to Apply for Job: September 28, 2026 Additional Location Information: Global - Any Pfizer Site, USA - Any Pfizer Site Eligible for Relocation Package – NO Secondment 12 months If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information. There will be no change to your current work location. Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office). This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview. 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. 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 provider’s 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 accessible 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. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers . Engineering