Regulatory Affairs-Canada

0 - 2 years

3 - 5 Lacs

Posted:4 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Preparation and update Auros Product Monograph by referencing Canadian Reference Product (CRP) Monograph and also following with PM guidance / HC master template.
  • Preparation of Auro’s Label by referencing CRP label and in line with the HC labeling guidance.
  • Preparation and review of Module 1 and Module 5 documents for ANDS, SANDS labeling and Level III Submissions in timely manner.
  • Collaborate with the RA Canada team on safety-related submissions such as Advisement Letters and Level III changes.
  • Co-Ordinating with artworks preparations team for development of label / cartons / package insert for ANDS / SANDS labeling submission purpose.

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Aurobindo Pharma logo
Aurobindo Pharma

Pharmaceuticals

Hyderabad

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