Home Regulatory Affairs Executive Regulatory | Pfizer Ltd | Chennai, TN

Executive Regulatory | Pfizer Ltd | Chennai, TN


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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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