About the Job :
Experience : 5-7 years in masters of pharmacy of life sciences, preferably in Multi national companies
Able to communicate effectively with global teams
Problem solving skills and presentation skills
Need to have excellent inter personal skills with multi tasking ability
Need ti have awareness on updated regulatory guidelines
Job requirement :
- Need to Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
- Co ordinate In liaison with his/her manager, can be involved in activities such as shortages, DHPC, B/R reevaluation, etc.
- candidate should Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate.
- Develop the Blue Print initiative, Develop regulatory strategy and provide regulatory expertise within project/product teams for products under development and/or marketed products,
- indulge in the Interface with various project/product teams.
- Handling to Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
- Able to maintain the Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies..
- possess the maintenance of a portfolio of products.
- Need to ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
- Able to provide support and communicating information on products to other functions (approvals, ...).
- Adhere and update with the regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
- Responsible for keeping the databases updated on a timely basis for portfolio he/she is in charge of.