Manager

JOB RESPONSIBILITIES

To support ISBU through new and renewal dossier submission, pre-registration recommendation response preparation and share with Customer for new and renewal dossier submission, update dossier as per post approval changes through filling variation.

1. Preparation, review and submission of new as well as renewal dossiers for registration in LATAM.
2. Response to customer and respective MoH queries from LATAM region on Dossiers and submitted documents within stipulated timeline.
3. Review and approve technical documents (change controls, specifications, stability protocol, MMD II and art works etc.) for regulatory submissions as well as post approval compliance.
4. Review and approve SAP orders for LATAM markets for all customers.
5. Establish Co-ordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within period.
6. Prepare/update project trackers related to approve products, on-going registrations, new projects and query response.
7. To maintain appropriate database for registration related activities.
8. To coordinate with support functions for smooth execution of dossier plan and submission of query response.
9. To educate the team members on regular basis for ongoing projects and any update in Registration guideline.
10. To support ISBU and RA team for any unplanned priorities including tender submissions to support the business for LATAM.