Pfizer Vacancy for Associate I – Regulatory Conformance Position Apply Now

Pfizer Vacancy for Associate I – Regulatory Conformance Position Apply Now

Associate I – Regulatory Conformance

Job Description

Committed to quality and excellence in compliance and conformance.

• With the reasonable understanding of Regional Regulations, would perform the evaluation of the notifications assigned.

• Accountable for maintaining the RA status in corporate change and dossier management system for the allocated Regions / Markets

• Contributes independently and manages own time to meet the timelines.

• Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time.

• Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system.

• Makes informed decisions on straight cases within guidelines and policies

• Operate in line with internal SOPs and policies

• Escalate any potential compliance issues to management

• Support periodic and ad-hoc system reports to estimate metrics

• Assist in remediation activities

Qualifications

Must-Have

  • Bachelor’s Degree
  • Demonstrated experience
  • Proven ability to consistently deliver to time, cost and quality standards
  • Operational knowledge of hardware and software tools required for the job
  • Excellent organizational skills and attention to detail
  • Knowledge of documentation practices
  • Fluent in English, verbal and written 
  • Nice-to-Have
  • Project Management experience
  • Knowledge across multiple therapeutic areas

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

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