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/partnerinterests.
• 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 bachelors degree with at least 5 years of experience; OR a masters degree with at least 3 years of experience; OR a PhD with 0 years of experience; OR as associates 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
• Secondment12 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 for12 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).

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.

To learn more about acceptable and prohibited uses of AI during the recruitment process please review our candidate AI-use guidelines available onPfizer Careers.