Job Criteria:
B.Pharm or M.Pharm qualification having experience between 7 - 15 yrs. with dossier filling experience in MEXICO or South East Asian Countries.
Knowledge for review of quality documents like executed batch documents, method validation, change
Positive communication skill

Job Responsibility:
Compilation and review of product license applications, variations, and renewals for Mexico country as per regulatory requirements respectively with minimal supervision
Manages electronic documents and creates electronic submissions in CTD format.
Preparation and review of responses to authority questions during registration and product lifecycle.
Keep track of assigned projects and follow-ups to ensure the Dossier is delivered as per set timeline/commitments.
Designing, Reviewing & Approval of Artwork required for registration purposes. •Dossier due diligence for products being in-licensed from other company
Support in preparing the meeting materials as needed, eg, regulatory project status/ submission/ approval information monthly, quarterly or yearly.

📌 Sr Executive/assist Manager/dy Manager Regulatory Affairs Vadodara (India)
🏢 Alembic Pharmaceuticals
📍 India