Senior Manager - Drug Regulatory Affairs

Key Responsibilities :

- Preparation of Administrative Module of US & Canada submissions

- Updating and quality control of change-control system of Life cycle management of Marketing Authorizations

- Local Pharmacovigilance link with QPPV (Qualified Person for Pharmacovigilance)

Skills Required :

- Proficient with preparation of application form and administrative part for new submissions and variations for submissions in US & Canada

- Proficient with preparation of SmPC, label and package leaflet texts

- Proficient with publishing and uploading of eCTD (electronic CTD) submissions

- Proficient with PV and SDEA activities

- Proficient in maintaining XEVMP database

- Knowledge of various marketing authorization procedures of US & Canada

- Adept with co-ordination for readability testing of PIL; creation expert report module 2.4 and 2.5 with expert signatures; creation of artworks + mock ups; translations; submission of PSUR and Risk Management Plans

Harish Dhamija
TeamEpic