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Regulatory Affairs Associate

Regulatory Affairs Associate

Smart Lion

0 - 1 years

0 - 3 Lacs

ahmedabad

Posted:8 hours ago| Platform:

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Skills Required

regulatory affairs drug regulatory affairs fda compilation regulatory nda glp ectd gdp ich-gcp anda ema cgmp edqm dmf qa ra who regulatory audits dossier preparation submission documentation gmp ra ich regulatory submissions usfda ctd filing dossier compliance operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Regulatory Affairs Associate
Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities.

Required Candidate profile

BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

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Regulatory Affairs Associate