Our client is currently seeking a driven and ambitious Director of Regulatory Process to join their team. This is a unique opportunity for a highly motivated professional who has a go-getter attitude.
1) Contribute to the development and implementation of procedures and policies for regulation of marketed promotional materials
2) Develop strategies for regulatory approval and introduction of new products to market
3) Manage the process from development of regulatory strategies through to approval
4) Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval
5) Ensure that all regulatory-related policies and procedures are current in accordance with applicable regulations and standards
6) Provide regulatory guidance and support to project teams, including regulatory filing strategies, testing and standards requirements
7) Establish appropriate risk analysis activities which include the use of risk analysis tools
8) Provide update on regulatory requirement changes, which affect individual product specification or quality systems
9) Establish solutions to regulatory problems utilizing novel approaches when required
10) Foster collaborative, efficient and effective working relations with regulatory authorities such as FDA
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