- 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.