• Cambodia
  • India
  • Kazakhstan
  • Kenya
  • Malaysia
  • Moldova
  • Myanmar
  • Philippines
  • Tajikistan
  • Ukraine
  • Uzbekistan
  • Vietnam
Senior Executive – Regulatory Affairs

Senior Executive – Regulatory Affairs

Senior Executive – Regulatory Affairs

Executive Okhla 600000 Regulatory Affairs

Job Details

  • Understanding of ICH, USFDA, WHO guidelines of regulatory.
  • Review of technical documents i.e. API row data, BMR, PVP/PVR.
  • Knowledge of reviewing analytical validation, DMF

Duties

  • Understanding of ICH, USFDA, WHO guidelines of regulatory.
  • Review of technical documents i.e. API row data, BMR, PVP/PVR.
  • Knowledge of reviewing analytical validation, DMF.
  • Sound knowledge of ICH guidelines.
  • Handled filing of semi-regulated market & post approval changes.

Skills

  • Command over written and verbal English communication.
  • Working Knowledge of Mexico, Brazil, Australia, South Africa, New Zealand & Malaysia.
  • Proficient in computer skills
  • Commitment and ownership.
  • Proactive and problem solving approach
  • Ability to work with tight timelines.

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