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Executive | Regulatory Affairs Manager (Aus & NZ) | Indoco Remedies | Mumbai | 7-9 Lakhs

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Indoco Remedies Ltd. is a fully integrated, research-oriented pharma company engaged in the manufacturing and marketing of Formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs).

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We have seven decades of presence in the Indian Pharma market and a strong foothold in the international market across 55 countries. Indoco, a USD 161 million company, employs over 5500 people, including over 300 skilled scientists.

Positions: Regulatory Affairs Manager – Australia & New Zealand

Location: Mumbai, Maharashtra

Job Description:

  • Compilation and submission of Dossier (ANDA) for US-FDA.
  • Compilation and submission of Dossier for Australia New Zealand
  • Review of Chemistry manufacturing and control documents (CMC) documents like BMR, Process Validation, FP/API/PM/RM Specification, Stability protocol & reports
  • Experience of handling deficiency response
  • Evaluation of post-approval changes and submission
  • Candidate should have experience in Sterile Dosage forms.

Qualification: B.Pharma/M.Pharma

Experience: 5-8 Years

Salary: 7,00,000 to 9,00,000 INR (CTC/PA)

Contact Details:

Ms. Gauri Mahesh Deo

gauri.deo@indoco.com, hr@indoco.com, 

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