Technical and Regulatory Affairs Manager (Secondment - 12 Months)

Pfizer•Kalamazoo, MI

1d•Hybrid

About The Position

This 12-month 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.

Requirements

Working knowledge of pharmaceutical development, manufacturing, quality, or CMC regulatory requirements.
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.
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 an 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.
Permanent work authorization in the United States.

Nice To Haves

Experience with APIs or intermediates is preferred.
Experience with regulatory change systems, quality systems, document management platforms, dashboards, automation tools, SAP, or Salesforce is desirable.

Responsibilities

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.
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.
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.
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.