Empleos actuales relacionados con Global Regulatory Affairs - Buenos Aires - Eli Lilly and

  • Regulatory Affairs Manager

    hace 7 días

    Buenos Aires, Buenos Aires C.F., Argentina Kaizen Gaming A tiempo completo

    Let's start with the roleThe Regulatory Affairs Manager will oversee Kaizen Gaming's regulatory compliance and public affairs strategy, ensuring full adherence to gaming regulations while actively shaping policy at local and international levels. This role serves as the company's representative to regulators and industry stakeholders, driving compliance and...

  • Associate Director, Regulatory Affairs

    hace 1 semana

    Buenos Aires, Argentina IQVIA A tiempo completo

    **We are looking for a forward-thinking, metrics-driven leader with study start-up experience, who has served as a Department Head and brings cross-functional and strategic expertise. This role will involve managing 8-10 direct reports and requires strong financial acumen to drive success.** Job Overview Line Management responsibilities for a team of...

  • Regulatory Affairs Sr Manager

    hace 3 horas

    Capital Federal, Buenos Aires, Argentina Medison Pharma A tiempo completo

    Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases._ - Medison is rapidly growing in the international markets...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Buenos Aires, Argentina Prometeo Talent A tiempo completo

    Regulatory Affairs Specialist – Regulatory Affairs / Southern Cone At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more...

  • Regulatory Affairs

    hace 3 horas

    Buenos Aires, Argentina Serviap A tiempo completo

    **Job Description Form** Consumer - Regulatory Affairs **Department / Project **( OTC+Cosmetics+Food and **Job Title **Team Lead Dietary Supplements) **Duties and Responsibilities** **Regulatory Strategist/ Specialist**: - Complete Regulatory Support - providing regulatory services/ support for client projects for assigned markets. - Markets assigned...

  • Hybrid Regulatory Affairs Specialist

    hace 2 semanas

    Buenos Aires, Argentina Medtronic plc A tiempo completo

    A global medical technology leader is seeking a Regulatory Affairs Specialist in Buenos Aires. This position requires a bachelor's degree in relevant fields and fluency in English, with over two years of regulatory affairs experience. The role involves direct coordination for regulatory submissions, compliance recommendations, and monitoring of regulatory...

  • Regulatory Affairs Specialist

    hace 4 días

    Buenos Aires, Argentina Avra Talent A tiempo completo

    Regulatory Affairs Specialist Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier everyday. But what really makes it work at...

  • Manager, Regulatory Affairs, International

    hace 1 semana

    Buenos Aires, Argentina Novasyte A tiempo completo

    Introduction/Purpose The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and...

  • Regulatory Affairs Lead

    hace 3 semanas

    Buenos Aires, Argentina Perfil Humano A tiempo completo

    A global pharmaceutical company is seeking an experienced Regulatory Affairs professional based in Buenos Aires, Argentina. The successful candidate will manage all regulatory activities and quality assurance across the South Cone region, including Chile, Uruguay, and Paraguay. Candidates should have over 6 years of experience in the pharmaceutical industry,...

  • Senior Regulatory Affairs

    hace 3 semanas

    Buenos Aires, Argentina linscaninspection A tiempo completo

    A global pharmaceutical company is seeking a Regulatory Affairs & Pharmacovigilance Manager in Buenos Aires. The role involves managing regulatory affairs operations, establishing quality management systems, and acting as the Technical Director. Candidates must have a Bachelor's degree in Pharmacy and at least 6 years of pharmaceutical industry experience,...

Global Regulatory Affairs

hace 4 semanas

Buenos Aires, Argentina Eli Lilly and A tiempo completo

Overview: The purpose of the Spanish-Multi Market Labeling Coordinator is to: Support labeling development carried out by external partners who hold local product licenses for Lilly manufactured products in Latin America, where Spanish Multi Market Labelling (SP-MML) is used. This role also prepares and provides Affiliates and external partners with timely and complete regulatory submission packages to support both new and revised MML, ensuring alignment with Reference Country labelling and meeting internal as well as external expectations. The Coordinator serves as a central point of coordination and communication with global and cross‑functional teams, and may also support country‑specific packaging development in place of an affiliate ALRP when requested. In fulfilling these responsibilities, the Coordinator drives the timely submission and implementation of labeling changes to ensure that both regulatory and internal timelines are met, demonstrates a thorough understanding of the labeling implementation process and its impact, communicates the implications of labeling changes to cross‑functional partners, and develops submission and implementation plans that capitalize on opportunities to bundle changes for more efficient execution when appropriate. Responsibilities: Key Tasks: Serve as a labelling resource for regulatory to develop and gain support for strategies and concepts that will deliver timely labelling for new and marketed products. Support labeling development executed by external partners holding local product licenses of Lilly manufactured products on their own behalf. Act as a delegate for Affiliate labelling responsible person (ALRP) outlined in the Labelling Development and Maintenance standard. Liaise closely with GRA Regional Regulatory Scientists and Manufacturing/Supply Chain on the creation of new MML to support product launch. Manage ARF and Truth/Proof Process including any needed translations to create new and updated MMLs and provide required submission documents to affiliate ALRPs and/or External Partner. Drive the maintenance of marketed product MML in line with reference label, internal timelines and bundling decisions. Monitor, support and drive the implementation of updated or new labelling components into the market. Maintain the MML strategic plan. Monitor reference country product labels for planned implementation in MML. Maintain up-to-date knowledge of submission statuses, requirements, and conditions of MML markets. Network with global manufacturing site functions such as Supply Chain, Manufacturing, Regulatory and Printing, Packaging and Development to develop labelling materials, acquire submission documents and plan, and manage MML production decisions. Create Veeva Vault RIM entries when needed for each impacted market for planning, tracking and status reporting purposes and ensure that data in Veeva Vault RIM and BLUE are accurate at all times. Recognize complex labelling scenarios that require solutions. Identify potential solutions. Escalate when necessary. Apply knowledge of business processes and labelling to gain alignment with partners on standardized processes and labelling deliverables. Provide ALRP and external partner training including the use of Veeva Vault RIM and BLUE to ensure accurate data capture. Process information and team/audience dynamics and adapt style when negotiating with cross functional partners to enable effective decision‑making and timely completion of deliverables. As required, as delegate ALRP, perform tasks related to country‑specific labelling in collaboration with the Regional Labelling Coordinator. Support and collaborate with other Labeling Coordinators as capacity allows. Utilize regulatory labeling and process expertise to drive consistency and influence effective change management for labeling processes optimization. Other GRA regulatory initiatives Functional and Technical Expertise Develop, improve, and maintain tools to retain labeling information. Lead, partner and influence labeling‑related activities throughout the product lifecycle, including communication with affiliates for submission activities related to the ARF process and samples and implementation of local labeling. Understand and communicate manufacturing impact (cost and resources) associated with labeling changes. Share timely information with other Labeling Coordinators to capitalize on best practices. Educate affiliates and external partner, when necessary, on regulatory requirements, roles, and responsibilities, labeling best practices and the process to ensure high quality translations and timely implementation of new or revised labeling. Basic Requirements: Education Requirements: Bachelor’s degree in a scientific or health sciences discipline (or equivalent experience). Fluent (speaking and reading/writing) in Spanish and English Demonstrated attention to detail. Demonstrated ability to multitask, plan, prioritize and project manage. Demonstrated computer skills (Word, Excel, Power Point) Ability to work independently Good communication skills Demonstrated agility to learn new IT systems/tools. Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles. Demonstrated problem solving skills. Additional Skills/Preferences: Understanding and knowledge of medicines. Previous coordinator role or Project management experience. Understanding and knowledge of the emerging market environment and regulations Regulatory experience in an affiliate office Use of databases relevant to regulatory business. Additional Information: This role may be located in Argentina, Brazil, Colombia, Costa Rica, Mexico or Peru. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly #J-18808-Ljbffr