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At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer

Position: Executive Regulatory Affairs

Location: Chennai, Tamil Nadu

Job Description:

  • Committed to quality and excellence in compliance and conformance
  • Accountable for maintaining the corporate change and dossier management system regarding the status of regulatory CMC submissions with global health authorities per internal SOPs and BU’s requirement.
  • Ensures timely communication of any issues e.g. Board of Health queries to the regional teams as needed

  • Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process.
  • Responsible for making updates for all submission types upon receipt of notification of Submission and Approval evidence
  • Providing accurate updates in PDM and consult with concerned colleagues for clarification of any discrepancies, before updating PDM.
  • Support for updates in PDM for withdrawals of products registered
  • Operate to the highest conformance and quality standards
  • Operate in line with internal SOPs and policies
  • Manage status updates of global CMC submissions within the corporate change and dossier management system
  • Adhere to standard turnaround timelines
  • Escalate any potential compliance issues to management
  • Liaise with regulatory colleagues to communicate and resolve potential issues
  • Provide input to continuously improve and streamline the submission process
  • Support periodic and ad-hoc system reports estimating metrics
  • Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation, and talent development and retention.
  • Assist in ensuring internal regulatory processes and procedures are well documented

Qualification: B.Pharma/M.Pharma

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