Officer/ Executive - Regulatory Affairs

Konnect HR
  • Pune
  • Confidential
  • 3-5 years
  • Views
  • 05 Jun 2018

  • Medical Services

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Officer/Executive - Regulatory Affairs - API - Pharma (3-5 yrs) - DMF compilation and Reviewing for US and Canada market. - Deficiency response, life cycle of DMF and change control review.Thorough knowledge of ICH and US DMF guidelines. - Knowledge of Educe and Docubridge software. Analytical and Reviewing skills. Desired Candidate Profile : - DMF compilation and Reviewing for US and Canada market. - Knowledge of Educe and Docubridge software. - Analytical and Reviewing skills. - Good presentation skills.


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Konnect HR