Technical and Regulatory Affairs Manager – Secondment, 12 Months

Pfizer

. Provide integrated technical, quality, and regulatory support across the lifecycle of assigned PC1 APIs and intermediates .

Posted 9/21/2026full-timeKalamazoo • Michigan • United StatesSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in CMC Regulatory Lifecycle Management, Technical Documentation, and Regulatory Submissions, with a strong focus on quality assurance and customer engagement. Proficient in analyzing complex information and developing practical recommendations while managing multiple priorities in a regulated environment.

Highest-signal resume keywords

CMC Regulatory Lifecycle ManagementTechnical Documentation SupportRegulatory SubmissionsRisk ManagementStakeholder Management

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Pharmaceutical DevelopmentRegulatory RequirementsChange AssessmentGovernance CommunicationAnalytical Methods

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationAttention to DetailPlanning SkillsInfluencing Skills

Tools & Technologies

Microsoft 365

Industry Keywords

Quality AgreementsDrug Master FilesActive Substance Master FilesRegulatory Document RequestsCustomer Audits

About the role

Key responsibilities & impact

Provide integrated technical, quality, and regulatory support across the lifecycle of assigned PC1 APIs and intermediates
Serve as a technical and regulatory point of contact for assigned customers, distributors, products, or markets
Coordinate responses to customer inquiries involving processes, specifications, impurities, stability, analytical methods, technical declarations, and supporting documentation
Support quality agreements, customer audits, confidentiality agreements, regulatory document requests, and access to reference standards
Coordinate communications regarding complaints, deviations, out-of-specification or out-of-trend results, supply events, and other technical matters
Maintain customer-facing technical documentation and product files
Maintain global regulatory dossiers, including Drug Master Files, Active Substance Master Files, annual reports, amendments, variations, and lifecycle records
Prepare, review, coordinate, or submit regulatory documentation according to 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
Monitor regulatory commitments, submission calendars, trackers, status logs, and dashboards
Support inspections and health authority interactions
Assess technical and regulatory impacts of manufacturing, analytical, specification, process, and site changes
Develop regulatory strategies, customer communications, and mitigation actions with cross-functional experts
Provide regulatory risk assessments, governance updates, and recommendations to PC1 leadership
Support market expansion requests and external partner engagement
Coordinate priorities and workload across technical and regulatory activities
Drive continuous improvement through templates, knowledge management, metrics, dashboards, and automation
Complete a sustainable secondment capstone or improvement initiative

Requirements

What you’ll need

Bachelor's degree with at least 5+ years of experience; OR master's degree with at least 3+ years of experience; OR PhD with 0+ years of experience; OR associate's degree with 8+ years of experience; OR high school diploma (or equivalent) and 10+ years of relevant experience
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
Practical experience in CMC regulatory lifecycle management, technical customer support, change assessment, risk management, and governance communication
Ability to analyze complex information, identify risk, and develop clear, practical recommendations
Strong written and verbal communication skills
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
Candidates must be authorized to be employed in the U.S. by any employer
Position requires permanent work authorization in the United States
U.S. work visa sponsorship is not available now or in the future

Benefits

Comp & perks

Flexible work arrangement; approximately 2.5 days per week in office under Log In For Your Day requirements
Relocation assistance may be available based on business needs and/or eligibility
Secondment opportunity for 12 months
Professional development through cross-functional exposure and capability building
Defined secondment capstone or improvement initiative
Knowledge transfer and documented transition plan at assignment conclusion