Regional regulatory affairs manager – São Paulo/SP

Responsabilidades

• Develop and inform strategies and plans to help Human Nutrition Latin America business successfully navigate the regulatory landscape and develop effective strategies for market entry.
• Ensure that all Latin America Human Nutrition products adhere to applicable regulations locally and in export countries.
• Stay updated on and understand the ever-changing Latin America regulatory environment and provide the business input on the potential implications and relevant actions.
• Lead the team to prepare and submit dossiers to regulatory agencies and engage authorities so as to obtain and maintain market authorization for Latin America Human Nutrition products.
• Provide strategic and technical advice to R&D, Quality and Commercial teams on scientific aspects and regulatory requirements that may have implications for product development.
• Act as the key liaison between ADM and regulatory authorities, facilitating communication and ensuring the compliance of the Human Nutrition portfolio with regulatory requirements.
• Monitor for any adverse events after a product is on the market, ensuring that significant issues are reported to regulatory agencies and collaborate with relevant internal stakeholders to ensure appropriate corrective actions are implemented.
• Collaborate and support Quality to ensure that Human Nutrition products meet the food safety and quality and that regulatory audits.
• Enhance culture, engagement and collaboration, advance training and career development, and enable talent pipeline and succession planning.
• Introduce and leverage processes and tools, prioritize high value work and ensure clearly articulated and appropriate role sort across the Human Nutrition product portfolio.
• Proactively and continuously collaborate with relevant internal teams including R&D, quality, legal, GR, commercial, etc.
• Advance routines and engagement with trade associations and regulatory authorities to help shape and inform imminent and future regulations relevant to Human Nutrition product categories.

Requisitos

• A relevant Bachelor or higher degree in natural science (chemistry, biology, food science, pharmacy), nutrition, food law or other related field or equivalent experience.
• Regional and global regulatory experience in food and food ingredients.
• Knowledge across a wide range of food products including manufacturing and technical systems.
• Experience leading and developing a regulatory affairs team including some remote team members.
• Ability to work in a team environment and having a cross-functional and multi-cultural approach.
• Extensive experience engaging with external stakeholders – trade associations and regulatory authorities.
• Strong engagement and collaboration with internal stakeholders including Quality, R&D, Operations, Commercial, etc.
• Ability to provide regulatory solutions and identify opportunities to drive regulatory compliance efficiency and effectiveness.
• Excellent communication, presentation and organizational skills, in both spoken and written English, Spanish and Portuguese.
• Experience engaging and communicating with business leaders highlighting opportunities for mitigating regulatory risks and leveraging regulatory opportunities.
• Computer Skills and excellent user knowledge in business relevant software (SAP, Microsoft Office Package).
• Strong execution capabilities with ability to handle multiple assignments and manage major projects to successful competition.
• Full understanding of local, regional and global food industry regulatory landscape and potential business implications.
• Possess communication skills that can relate regulatory topics to non-regulatory audiences and ties this into business context.
• Ability to focus priorities and work under pressure to meet deadlines.
• Teaching, communication and empowering skills.
• Ability to identify employee’s capabilities and distributes group responsibilities to capitalize on previous experience and expertise.
• Entrepreneurial approach, business acumen and positive, can-do attitude with open minded approach.

Marcado como: ANVISA, Assuntos Regulatórios, Compliance, Legislação Sanitária, Normas Regulatórias