Regulatory Affairs Coordinator

Descripción del empleo Este es un puesto de trabajo remoto. Overview: We are seeking a highly skilled and motivated Regulatory Affairs Coordinator to join our multinational pharmaceutical company, specializing in synthetic chemical molecules. The ideal candidate will have extensive experience in regulatory submissions and a deep understanding of the regulatory landscape in Argentina. Key Responsibilities: Regulatory Submissions: Prepare, review, and submit regulatory dossiers to ANMAT (National Administration of Drugs, Food and Medical Technology) and ensure compliance with local regulations. Regulatory Strategy: Develop and implement regulatory strategies for new product approvals and variations, ensuring alignment with corporate objectives. Liaison with Regulatory Authorities: Act as the primary point of contact with regulatory authorities, responding to inquiries and facilitating inspections as necessary. Documentation Management: Maintain organized records of all regulatory submissions, correspondence, and documents related to product registration and compliance. Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, and Marketing teams to ensure timely and effective regulatory input throughout the product lifecycle. Market Intelligence: Monitor changes in regulatory policies and guidelines in Argentina and provide strategic advice to the organization. Training and Support: Provide training and support to internal teams on regulatory requirements and best practices. Requisitos Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred. Minimum of [X] years of experience in regulatory affairs within the pharmaceutical industry, specifically with a focus on synthetic chemical molecules. Proven track record of successfully submitting regulatory dossiers to ANMAT. Strong knowledge of regulatory guidelines and procedures in Argentina. Excellent communication skills in both English and Spanish, with the ability to convey complex information clearly. Strong organizational skills and attention to detail. Ability to work independently and collaboratively in a fast-paced environment. Estoy interesado