.Description Kenvue is currently recruiting for:Regulatory Affairs SpecialistThis position reports into GRA CMC Regulatory Affairs Manager and is based at Mexico City. Who we areAt Kenvue, part of the Johnson & Johnson Family of Companies, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID —are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers' hearts and homes.What you will doThe Regulatory Affairs Specialist is responsible for ensuring compliance with regulatory agency regulations and interpretations, preparing responses to regulatory agencies' questions and other correspondence, and organizing and maintaining reporting schedules for new drug applications and investigational new drug applications. This is a fixed-term 12-month position.Key Responsibilities:Develop and maintain regulatory strategies and submissions for new products and changes to existing products in alignment with industry standards and regulations.Collaborate with cross-functional teams to ensure compliance with regulatory requirements throughout the product development lifecycle.Provide guidance and support to internal stakeholders on regulatory matters, including labeling, advertising, and promotional materials.Stay up-to-date with changes in regulations and industry standards, and communicate potential impacts to the organization.Contribute to the development and implementation of quality systems and processes to ensure compliance with regulatory requirements.Participate in regulatory agency inspections and audits, and assist with the resolution of any findings or observations.Develop and execute regulatory strategies to ensure compliance with global, regional, and local regulations and guidelines.Prepare and compile high-quality regulatory submissions, responses to regulatory agencies' questions, and other correspondence in accordance with regulatory agency regulations and guidelines.Review and approve artwork and promotional copy material to ensure regulatory compliance.Maintain and archive regulatory documentation in accordance with regulatory agency regulations and guidelines.Present status updates on product/project activities to key internal/external stakeholders.Assist in the development of best practices for Regulatory Affairs processes. Qualifications What we are looking forRequired Qualifications:Bachelor's degree in a scientific or healthcare-related field.2-4 years of experience in regulatory affairs.Strong knowledge of COFEPRIS and FDA regulations and guidelines, as well as experience with international regulatory requirements
