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Regulatory Affairs Specialist

hace 2 meses


Ciudad de México, Ciudad de México Kenvue A tiempo completo

Kenvue is a leading healthcare company that is part of the Johnson & Johnson Family of Companies. We are currently seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico City. The successful candidate will be 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. The ideal candidate will have a strong knowledge of COFEPRIS and FDA regulations and guidelines, as well as experience with international regulatory requirements. Excellent communication and interpersonal skills are essential for this role. The successful candidate will also have the ability to work independently and prioritize tasks in a fast-paced environment. If you are a detail-oriented individual with strong organizational and project management skills, we encourage you to apply for this exciting opportunity. As a Regulatory Affairs Specialist at Kenvue, you will have the opportunity to work on a variety of projects and contribute to the development and implementation of quality systems and processes to ensure compliance with regulatory requirements. You will also have the chance to participate in regulatory agency inspections and audits, and assist with the resolution of any findings or observations. In addition, you will be responsible for preparing and compiling high-quality regulatory submissions, responses to regulatory agencies' questions, and other correspondence in accordance with regulatory agency regulations and guidelines. If you are a motivated and organized individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity. The successful candidate will have the opportunity to work in a dynamic and collaborative environment, and will be supported by a team of experienced professionals. We offer a competitive benefit package, including paid company holidays, paid vacation, volunteer time, summer Fridays, and more. We are proud to be an Equal Opportunity Employer and welcome applications from diverse candidates. If you are interested in this exciting opportunity, please submit your application. We look forward to hearing from you.