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Job Title: Junior Manager, Regulatory Affairs

Location: MDPL-TC, Gummadidala

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Salary: Not Disclosed

Experience: 5 – 8 years

Job Description:

  • Compile and submit DMF to regulatory authorities.
  • Address and submit responses to deficiencies within specified time frames.
  • Lead cross-functional team (CFT) meetings for deficiency-related activities.
  • Respond promptly to customer queries.
  • Evaluate and manage change controls as per regulatory variation guidelines.
  • Oversee lifecycle management for regulatory submissions.
  • Maintain regulatory submission databases.
  • Proficient in eCTD submission software.

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