Health and Safety Engineering, Health/Safety - Codes and Standards, Health/Safety - Inspection, Health/Safety - Quality
Principal Duties and Responsibilities:
Assist senior management in developing, and lead the implementation and execution of company strategy related to compliance of FDA regulated OTCs, devices and cosmetics.
Manage organization's vendor qualification initiatives for OTCs, medical devices and cosmetics in collaboration with cross-functional team members and 3rd party resources.
Manage review and approval process for the release of Private Labeled OTCs products.
Manage packaging process for OTCs, medical devices and cosmetic products, including label reviews and tamper evident packaging.
Manage company process for warehousing and storage of OTCs, medical devices and cosmetic products.
Lead training sessions and workshops on best practices for associates and suppliers on FDA compliance.
Ensure that OTC products are properly registered and listed with regulatory authorities (US FDA and Health Canada)
Assist in the import compliance issues resolution and process refinement
Assist in the OTC product market withdrawal and recall program
Design, manage and communicate supplier status updates related to OTCs, medical devices and cosmetics.
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
Are you looking to join one of the best retail teams in America? We are the largest retailer (by store count) in North America with over 15,000 stores and $22B in sales consisting of Dollar Tree and Family Dollar. Dollar Tree| Family Dollar is creating a culture that provides a compelling place to shop, work and invest. This is essential to achieving our corporate goals and you can help us succeed in that by joining our growing team!