Regulatory Affairs

RESPONSIBILITIES:
• Accountable for the management of Regulatory specialists team in charge of development/maintenance projects ,
• Responsible for managing the regulatory strategy, the on-time delivery of compliant major submissions to Regulatory Agencies and for the delivery of responses to Regulatory Agencies questions ,
• Responsible to know, to adhere to and to advise others on Regulatory Authority regulations and guidance ,
• Ensure compliance of all regulatory activities with all applicable laws, regulations, Regulatory Authorities requirements and company procedures ,
• Provide guidance to various teams and stakeholders across the company organization on regulatory requirements/policies for development and marketed products ,
• Participate in discussions/meetings with Regulatory Authorities as required ,
• Participate in other projects and activities, such as leading implementation of changes to processes ,
• Accountable for keeping the databases updated on a timely basis for portfolio he/she is in charge of .
• Provide support and communicating information on products to other functions (submissions, approvals .. ,…etc)
• Liaise with HA contact person, organizing and preparing HA meeting and leading .
• Manage activities such as shortages, DHPC, B/R reevaluation, etc .