Principal Duties and Responsibilities:
Minimum Qualifications and Requirements:
Knowledge and understanding of FDA regulations, guidelines and best practices related to OTCs, medical devices and cosmetic products, including CGMPs, OTC drug monographs, labeling, NDA/ANDA filings and product/lot release.
Bachelor’s degree or above in Biological sciences, Chemistry, Pharmacy, Engineering or a related field.
7+ years of experience in a business, consulting, governmental or non-governmental organization focused on retail products.
Knowledge and understanding of US and Canadian OTC, medical devices and cosmetic regulatory requirements and ability to identify risks and opportunities.
Ability to work collaboratively, engage comfortably with senior executives, work effectively in cross-functional global organization
Organized and self-motivated, strong project management skills in order to multi-task and manage multiple projects simultaneously from beginning to end within a fast-paced environment with changing priorities.
This is not to be considered a complete list of job duties, as they may be amended or added to as needed