Prestige Consumer Healthcare brings product innovation and quality to over-the-counter healthcare products to better improve the lives of our customers and their families. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the largest independent provider of over-the-counter healthcare products in North America that continually improves and creates products that match the ever-changing lifestyles and needs of people globally.

Job Summary

Based in Prestige’s corporate headquarters in Tarrytown, NY, this entry-level position will report to the Sr. Director, Regulatory Affairs and will work with the company’s offices in the UK and Australia to identify and provide available documentation to support those markets’ registration and sale of Prestige’s U.S./Canadian drugs, medical devices, cosmetics, and dietary supplements. The Coordinator will consult with Prestige’s U.S.-based Regulatory Affairs and Quality Assurance groups to obtain current files, including product labeling, specifications, and manufacturing site information. The Coordinator will also apply to the U.S. FDA for export certificates, e.g., Certificates of Pharmaceutical Product (CPP) and Certificates to Foreign Government (CFG).

Major Responsibilities/Activities

• Coordinate product registrations and requests for other regulatory information.
• Correspond with local and federal governmental agencies and trade organizations as needed to obtain and legalize export certificates for cosmetics, medical devices, and OTC drugs.
• Prepare and submit required documents for international registrations, renewals, and variations.
• Assist in the development and implementation of international regulatory strategy.
• Assist in the review of new and revised international label copy to include compliance to applicable regulations.
• Communicate with ex-US Prestige Consumer Healthcare offices, international distributors, and consultants, as directed.
• Prepare implementation plans and timelines for Sr. Director’s approval.
• Foster close cooperative relationships with all functions in the company relative to RA compliance.
• Perform other related duties as required.

Minimum Requirements

• BA/BS degree, preferably in a scientific field
• International drug or cosmetic registration experience is preferred
• Ability to speak/write in a second language is preferred
• Able to work independently and managing multiple responsibilities with a sense of urgency
• Ability to perform detail-oriented work and organize/prioritize multiple deliverables
• Ability to analyze information and apply critical Thinking
• Effective verbal and written communication skills and demonstrated interpersonal skills
• High proficiency in computer skills, Microsoft Office/Adobe

This position is a hybrid role. Must be able to work in Tarrytown, NY on Tues/Weds/Thurs. Work from home on Mondays and Fridays.

*Sponsorship is not available for this role. *Relocation is not available for this role.

Salary Range: $60,000 - $70,000

Prestige is an Equal Opportunity Employer

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