Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters. The PositionA healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. The Opportunity: The Regulatory Affairs Specialist will be responsible for leading regulatory strategies and ensuring compliance across four countries: Argentina, Uruguay, Bolivia, and Paraguay, with a primary focus on Argentina. This role involves managing submissions to regulatory agencies, maintaining strong relationships with health authorities, and providing strategic advice to cross-functional teams. The position is based in Buenos Aires and reports directly to the Technical Director. Key Responsibilities:
Regulatory Strategy & Compliance:
Develop and implement regulatory strategies for Argentina, Uruguay, Bolivia, and Paraguay. Ensure that all products meet the necessary regulatory requirements for these markets, with a primary focus on Argentina. Stay updated on regulatory changes in the four countries and assess their impact on company operations. Manage the import permit process at ANMAT (14 puntos; Disposición ANMAT 2675/99). Regulatory Submissions:
Prepare, compile, and submit regulatory documents to relevant authorities in Argentina, Uruguay, Bolivia, and Paraguay for product approvals, renewals, and variations. Manage interactions and communications with regulatory agencies during the submission and approval process. Relationship Management with Health Authorities:
Establish and maintain strong relationships with health authorities in Argentina, and trade associations and support the interaction with other agencies of the network. Act as the primary liaison between the company and health authorities to facilitate smooth communication and collaboration (Argentina for dossiers evaluations). Attend meetings, workshops, and conferences hosted by health authorities to stay informed on regulatory trends and updates. Ensure that health authorities are kept informed of the company's regulatory activities, product launches, and compliance status. Cross-functional Collaboration:
Provide regulatory guidance to customer support, logistic, quality, and marketing teams to ensure compliance throughout the product development lifecycle, particularly in Argentina. Participate in cross-functional meetings to advise on regulatory requirements and timelines for all four countries. Support the development of product labeling, advertising, and promotional materials in line with regulatory guidelines. Post-market Surveillance & Compliance:
Monitor and manage post-market surveillance activities, including adverse event reporting and product recalls. Ensure ongoing compliance with regulatory requirements, including the maintenance of product registrations and licenses in all four countries. Conduct audits and inspections to assess compliance with regulatory standards. Documentation & Record Keeping:
Maintain accurate and complete regulatory files and records for Argentina, Uruguay, Bolivia, and Paraguay. Ensure that all documentation is compliant with regulatory requirements and is readily accessible for audits and inspections. Prepare and review regulatory reports and correspondence. Who you are: Education:
Bachelor's degree in Pharmacy, Regulatory Affairs, or a related field (Master's or Ph.D. preferred). Experience:
Significative experience in Regulatory Affairs, preferably working with Medical Devices Proven experience working with regulatory bodies and navigating regulatory processes in Argentina, Uruguay, Bolivia, and Paraguay. Experience in project management, including leading regulatory submissions and approvals. Technical Skills:
In-depth knowledge of regulatory guidelines, legislation, and requirements within the medical devices/pharmaceutical industry. Proficiency in regulatory submission software and tools. Strong analytical skills, with the ability to interpret complex regulatory documents and data. Fluency in both written and spoken English and Spanish is required. Additional Qualifications:
Knowledge of Good Manufacturing Practices (GMP) and Good Regulatory Practices (GRP). Experience with electronic submissions and familiarity with regulatory databases.
Relocation benefits are not available for this position.
Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Roche is an Equal Opportunity Employer.
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