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Role = Senior Regulatory Executive (Consumer Healthcare)
The Senior Regulatory Executive is Responsible for managing end to end development of regulatory source documents (e.g. manuscript). Includes collaborating with regulatory strategists and cross functional partners to collect and verify source documents, draft/create document from approved templates, maintain in Veeva along with version history.
• Ensure the accuracy of regulated product labelling content (e.g. Label Text/Manuscript) and specifications per input documents and requirements
• Perform artwork verification activities on content, graphics, symbols existing in different labelling components to support new product launches and base business projects to meet regulatory requirements
• Create and Maintain repository of current labelling documents in Veeva
• Author labelling contributions for Annual Reports in assigned portfolio. Manage all cross functional inputs, develop content, and meet all timelines for assigned reports.
• Assist in Content of Labeling/Drug Listing SPL generation and review, as needed. Establishment Registration experience a plus
• May provide support cross portfolio in one or more of the following consumer healthcare categories: OTC Drugs, Dietary Supplements, Medical Devices, Cosmetics
• Performs related duties as assigned
Knowledge/ Education / Previous Experience Required:
• Bachelor’s degree
• General understanding of US labelling regulations
• Veeva and/or i4i experience a plus
• Experience in 'Consumer' products is a plus
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.