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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
Location: Navi Mumbai, Mumbai Suburbs, Maharashtra
Job Description:
- Compilation and submission of Dossier (ANDA) for US-FDA.
- Review of Chemistry manufacturing and control documents (CMC) documents like BMR, Process Validation, FP/API/PM/RM Specification, Â 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 10,00,000 INR (CTC/PA)
Contact Details:
Ms. Gauri Mahesh Deo
gauri.deo@indoco.com, hr@indoco.com,Â
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