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Work/Life Balance

Time management

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Job Description

Key Responsibilities:

  • Ensure quality and excellence in compliance and conformance.
  • Evaluate notifications assigned with a reasonable understanding of regional regulations.
  • Maintain HA status in corporate change and dossier management systems.
  • Manage time independently to meet timelines.
  • Collaborate with GRA colleagues to identify and escalate gaps.
  • Perform accurate updates in the system for most cases and consult with Team Lead/Designee for complex cases.
  • Make informed decisions within guidelines and policies.
  • Support updates in the system for license withdrawals.
  • Operate in line with internal SOPs and policies.
  • Adhere to standard turnaround timelines.
  • Escalate potential compliance issues to management.
  • Support periodic and ad-hoc system reports to estimate metrics.
  • Contribute to local and regional regulatory initiatives aligned with Pfizer values.
  • Assist in ensuring internal regulatory processes and procedures are well documented.
  • Assist in remediation activities.
  • Support teams in ADHOC activities.
  • Share learning with team colleagues.

Technical Skills:

  • Theoretical knowledge of Regulatory Affairs/Compliance.
  • Experience in Regulatory/Quality Assurance/Production or other functions in the pharmaceutical or related industries.
  • Attention to detail and diligence.
  • Good communication skills.
  • Understanding stakeholder needs.

Candidate Profile:

  • Standards, processes, and policies knowledge of Pfizer.
  • Assertive, results-oriented, positive attitude, and time management skills.
  • Preferred qualifications: Master’s/Bachelor’s degree in Chemistry, Pharmacy, or related life sciences.
  • Preferred experience: 2 to 4 years in the pharmaceutical or relevant industry, preferably in regulatory, quality, or compliance roles.

Additional Information:

  • Experience: 2 to 4 years
  • Qualification: Master’s/Bachelor’s degree or equivalent
  • Location: Chennai
  • Industry Type: Pharma/Healthcare/Clinical research
  • Functional Area: Regulatory
  • End Date: 20th August 2024

Application Link

Pfizer Hiring Regulatory Conformance Associate

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