Regulatory Affairs Specialist managing complex product registrations and compliance in LATAM. Collaborating with regulatory authorities and providing documentation for approvals in the food sector.
Responsibilities
Execute complex and strategic product registration activities required for processes dealing with the Ministry of Health.
Ensure the provision of application files and prepare marketing authorization applications.
Provide additional documentation for registration revisions and renewals throughout the evaluation process.
Perform a follow-up on potential changes in a previously registered product and renewal deadlines for registrations.
Ensure efficient and effective archiving of all documentation.
May coach less experienced registration specialists.
Articulate and execute GRA Strategy for compliance.
Understand the overall role of Global Regulatory Affairs both internally and in relation to customers, regulatory authorities, and trade associations.
Responsible for the management and obtainment of regulatory approvals and registrations for all products and flavorings.
Direct interaction with regulatory authorities, coordination with external consultants and trade associations, and close collaboration with internal stakeholders to ensure timely approvals and ongoing regulatory compliance.
Provides customer support for flavors, colors, food ingredients/product safety and regulatory issues.
Requirements
Bachelor’s degree in Food Engineer, Pharmacy, Life Sciences, or related field.
Minimum 5 years of food regulatory affairs experience.
In-depth knowledge of the LATAM Argentina, South Cone and international regulations.
Strong communication and negotiation skills.
Fluency in Spanish and English.
Portuguese is plus.
Problem solving and decision making skills.
Strategic Thinking.
Collaboration.
Functional Technical Skills in relevant disciplines.
Expertise in Systems, AI, PowerBi, others is plus.
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