Regulatory Affairs Specialist For API - in Mumbai Location

8 - 10 years

12.0 - 15.0 Lacs P.A.

Mumbai, Mumbai (All Areas)

Posted:2 months ago| Platform: Naukri logo

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Skills Required

Regulatory AffairsDmfDrug Regulatory AffairsFDAPSUREurope MarketUS MarketEctdICHTGACapaUSFDAAndaDrug SafetyDossierCMCEDQMAnvisa

Work Mode

Work from Office

Job Type

Full Time

Job Description

- Must have good knowledge of Regulatory Submissions and Research - Must be familiarity with chemical industry specific regulations and guidelines. - Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies Required Candidate profile - Ensure company products with relevant regulatory requirements such as USFDA, FDA, EMA, and local regulations. - Stay up-to-date with changing regulatory requirement to internal stakeholders.

Human Resources Services
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