Pfizer

Regulatory Change Management Project Leader – 12 Months

Pfizer

full-time

Posted on:

Location Type: Hybrid

Location: McPherson • Kansas • United States

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Job Level

Senior

About the role

  • Works independently to manage key site changes with regulatory impact from initiation through submission to implementation and manages product holds for pending market activities.
  • Exercises own judgement leveraging knowledge and experience with minimal assistance from Management.
  • Provides peer leadership to mentor and develop other colleagues.
  • Supports license renewals in global markets, through the development of support strategies, and the preparation and submission of site documents to Pfizer colleagues globally with emphasis on supply equity.
  • Develops and reviews site responses to queries received from global Health Authorities.
  • Ensures communication of regulatory approvals to appropriate site personnel and PC1 customers.
  • Manages communication between PC1 customers, site SMEs and Regulatory Affairs, works with Reg Affairs to resolve issues, holds meetings with strategists and PC1 customers to discuss open regulatory impact assessments for proposed changes.
  • Completes impact assessments for key site change requests to document potential for regulatory impact and manage implementation.
  • May complete the CNM and/or PC1 customer section of Annual Product Reviews.
  • Manages Pfizer support of PC1 US annual report process.
  • Upkeep and development of department SOPs, monitoring alignment with regulations and Pfizer Quality Standards.

Requirements

  • 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.
  • Exceptional organizational and project management skills.
  • Demonstrated strength in analytical skills and meticulous attention to detail.
  • A solid understanding of the regulatory and audit frameworks pertinent to biopharmaceutical operations.
  • Proficiency in taking decisive action based on quality and compliance metrics and trends.
  • Capable of managing multiple complex projects with a strong sense of business acumen.
  • Excellent interpersonal effectiveness, coupled with superior written and verbal communication skills.
Benefits
  • Eligible for Relocation Package – NO
  • No routine travel, occasional travel 0-10%
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory impact assessmentproject managementanalytical skillsquality metricscompliance metricsSOP developmentsite document preparationimpact assessment documentationproduct hold managementlicense renewal support
Soft Skills
organizational skillsattention to detailinterpersonal effectivenesswritten communicationverbal communicationpeer leadershipdecisive actionbusiness acumenmentoringproblem-solving