Pfizer

Senior Associate – Contractor Regulatory Operations

Pfizer

full-time

Posted on:

Location Type: Hybrid

Location: Istanbul • Turkey

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Job Level

Senior

About the role

  • Support Post Approval Changes, initial registrations and/or renewals
  • Act as a regulatory expert, advising of regulatory strategy and potential supply constraints, if applicable
  • Act as a liaison between CMOs and internal Pfizer functions to ensure timely progression of regulatory activities
  • Monitor and notify regulatory submission status, BOH queries, commitments, and approvals
  • Support in Compliance Assessment and New Regulations/compendia requirements implementation as required
  • Coordinate the collection of supporting documents for Post Approval Changes, initial registration, renewals, BOH queries, and regulatory commitments
  • Support license renewals (e.g. GMP Clearance) and Tender applications
  • Manage routine complaints for commercial drug product and medical device and combination product

Requirements

  • Minimally 5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years with Master’s degree)
  • Expertise in Change Management and/or Regulatory
  • Experience with relevant QTS & eQMS modules
  • Demonstrated knowledge of US, European, Eurasia Economic Union (EUEA) and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices
  • Is diplomatic, clear & succinct in communication with internal and external stakeholders
  • Committed to the Change Management Best Practices to enable improvement of the Change Management Process and System
  • Embraces innovation and change to find solutions
  • Collaborative and embraces Pfizer mindset: Courage, Equity, Excellence, Joy
  • Proficient in English and technical writing
  • Good interpersonal and influential skills
  • Good verbal & written skills
  • Demonstrated success leading Projects
  • Decision-making based on a science-based risk approach
  • Ability to work with minimal supervision in a global organization
Benefits
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Applicant Tracking System Keywords

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Hard Skills & Tools
Regulatory AffairsChange ManagementcGMPQTS moduleseQMS modulesCompliance AssessmentTechnical WritingProject ManagementRisk Assessment
Soft Skills
Diplomatic CommunicationInterpersonal SkillsInfluential SkillsVerbal CommunicationWritten CommunicationCollaborationDecision-MakingAdaptabilityLeadership
Certifications
GMP Clearance