Global Regulatory Strategic Platform Analyst Puesto : Global Regulatory Strategic Platform Analyst Location: Bogota, Colombia About the job We are seeking a dedicated and detailed-oriented Regulatory Affairs Analyst to join our team. In this role, you will play a pivotal role ensuring compliance with local regulations and project requirements for medicines, cosmetics, medical devices, food and/or food supplements. At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing "Health in Your Hands". To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Main responsibilities: Preparation and Delivery: Take charge of preparing and delivering dossiers for Registration, Renewal and Post-approval variation, ensuring strict compliance with local regulations and project specifications. Technical Analysis: Conduct thorough technical analysis of all documents, focusing on regulatory classification. Risk Assessment: Prepare comprehensive risk assessments for dossiers before submission, evaluating technical feasibility and ensuring all necessary requirements are met. Deficiency Letters: Address deficiency letters issued by Health Authorities promptly and effectively. Safety and Effectiveness: Update harmonized package insert documents with the latest safety and effectiveness information. Communication and Coordination: Act as the focal point for communication with stakeholders. Database Management: Provide accurate and adequate information to keep the database and regulatory systems up-to-date. Problem Resolution: Provide senior management with visibility of key challenges faced locally. Effective Communication: Maintain open communication with LRA to assess the need and applicability of labeling updates. Submission Strategy: Coordinate the submission strategy for labeling updates. Artwork Evaluation: Evaluate the impact of safety and/or efficacy updates on harmonized artworks. Regulatory Compliance: Stay updated with regulations impacting labeling documents. Efficient Management: Maintain good communication with LRA and/or other regional areas. About you Experience: 1-2 years of relevant experience in a similar position. Experience working within an international company with a complex organizational environment. Soft skills and Technical skills: Strong knowledge of regulatory and labeling changes in countries under his/her responsibility. Demonstrated capacity for teamwork. Strong interpersonal/communication skills. Business and customer orientation. Knowledge in management of data in databases and working in workspace such as Document Management Systems. Proficient in the use of MS WORD, PowerPoint, Excel, Adobe Acrobat and collaborative work environment tools. Education: Bachelor's degree, or equivalent, in life sciences, regulatory affairs or related areas of study. Languages: Spanish - Native or bilingual proficiency. English - Professional working proficiency. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution. Take good care of yourself and your family with a wide range of health and wellbeing benefits. Play an instrumental part in creating best practice within our manufacturing facility. Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. #J-18808-Ljbffr