Global Regulatory Strategic Platform Analyst Location: Bogota, Colombia About the job We are seeking a dedicated and detail-oriented Regulatory Affairs Analyst to join our team. In this role, you will play a pivotal role in 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. Our priority is working with integrity to improve the health and well-being of people and communities where we operate. Main responsibilities: Preparation and Delivery: Take charge of preparing and delivering dossiers for Registration, Renewal, and Post-approval variation, including labeling, of various products, ensuring strict compliance with local regulations and project specifications. Technical Analysis: Conduct thorough technical analysis of all documents, focusing on regulatory classification. Complete dossiers for dispatch in accordance with the legislation of the respective country. 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, ensuring all necessary corrections and additional documentation are submitted as required. Safety and Effectiveness: Update harmonized package insert documents with the latest safety and effectiveness information, ensuring all labeling updates comply with country-specific requirements. Communication and Coordination: Act as the focal point for communication with stakeholders, including RSO, Global CMC, and Global labeling. Maintain effective communication channels to ensure smooth workflow. Database Management: Provide accurate and adequate information to keep the database and regulatory systems up-to-date, ensuring data accuracy and integrity. Problem Resolution: Provide senior management with visibility of key challenges faced locally, offering valuable insights and suggestions for improvement where applicable. Effective Communication: Maintain open communication with LRA to assess the need and applicability of labeling updates. Evaluate the impact of updates generated globally or regionally, ensuring harmonization and promptly communicate any deharmonization to key stakeholders. Submission Strategy: Coordinate the submission strategy for labeling updates, ensuring harmonization while minimizing regulatory, commercial, and industrial impacts. Artwork Evaluation: Evaluate the impact of safety and/or efficacy updates on harmonized artworks. Ensure timely updates of artwork text for submissions affected by safety and/or efficacy labeling changes. Regulatory Compliance: Stay updated with regulations impacting labeling documents for all countries under your responsibility. Propose innovative approaches to enhance labeling processes, fostering continuous improvement. Efficient Management: Maintain good communication with LRA and/or other regional areas to identify opportunities for an efficient management of labeling variations. 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 and recognized capacity to teamwork. Strong interpersonal/communication skills. Business and customer orientation. Demonstrated competencies: Act for Change; Cooperate Transversally; Strive for Results; Commitment to Customer; Think Strategically and Make Decisions. 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, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 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. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. #J-18808-Ljbffr
