Preparing, Reviewing and Submitting - Product Dossiers as per Country Specific guidelines
Preparing, Reviewing and Submitting - Renewal Dossiers / Variations.
Responding to queries raised by Regulatory authority of respective country.
Preparing CAPA reports for the audit or market complaints.
Coordinating with various department for Technical Documents as DMF, Stability data, FP COA, API COA, etc.
Coordinating Arranging for the registration samples as per country guideline.
Reviewing Approving the Artworks (Text Content)
Coordinating with FDCA Person for COPP GMP and its legalization process.
Updating all registration status records.
Maintaining Retain Samples Records.
Coordinating with customer for filing of dossier getting it timely approval.
SKILLS:
Fluent in English.
Positive communication skills.
Ability to work under pressure and to meet deadlines.

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📌 Executive International Regulatory Affairs Ahmedabad
🏢 Tashi Pharma
📍 Ahmedabad