The International Product Registration Specialist provides global regulatory and registration support to various projects and products. This position supports strategic planning and product development efforts as well as support for existing products with respect to product changes/modifications, labeling and promotional material review and approval. This individual will write, coordinate and complete the submission of regulatory documents to FDA and other international regulatory agencies. This includes International documents (e.g., Notification, Registrations). The International Product Registration Specialist prepares responses to FDA and international regulatory agency questions and other regulatory and product registration correspondence. This individual provides direct regulatory and registration support to project teams including the creation of global regulatory overviews and recommendations on global regulatory strategy, which includes in-depth team involvement with core team members (e.g. marketing, R&D). In addition, this individual will conduct product labeling and advertising review and approvals and evaluate proposed product modifications for Regulatory impact.

Job Tasks:

• ensuring regulatory and registration compliance across marketed products
• being a key member of a number of cross-functional teams working on both the development of product claims for labeling and promotion as well as the development and commercialization of new products
• providing regulatory and registration support/coordination of regulatory projects
• researching regulatory and registration issues, e.g. monograph status, labeling,
• obtaining essential documents and preparing regulatory master files for product registration
• coordinating the preparation of artwork for product launches in international markets

Job Qualifications:

Tasks of this position will include:

• 5+ years of international product registration experience
• ensuring regulatory and registration compliance across marketed products
• being a key member of a number of cross-functional teams working on both the development of product claims for labeling and promotion as well as the development and commercialization of new products
• providing regulatory support/coordination of regulatory projects
• researching regulatory and registration issues, e.g. monograph status, labeling,
• obtaining essential documents and preparing regulatory master files for product registration
• coordinating the preparation of artwork for product launches in international markets

Contact: Mark Ringger
Phone: 801-437-7970
Email: mringger@doterra.com

Please send a cover letter and resume to the listed email address