This is a fully remote position, open to applicants in Chile.

📋 Description

• Lead and provide support for submissions in the Latin American markets concerning Marketing Authorization Applications (MAAs) and life-cycle management processes.

• Serve as a local expert as part of the Global Regulatory Affairs team.

• Drive and coordinate the regulatory strategy along with local regulatory activities within Latin America.

• Offer regional regulatory expertise to facilitate geographical expansion.

• Monitor requests from Health Authorities and stay updated on new local regulations.

• Maintain up-to-date knowledge of local requirements and relay regulatory changes to senior management.

• Guide cross-functional Vertex teams through the planning, preparation, submission, and review processes for submissions.

• Draft responses to regulatory inquiries.

• Create timelines and develop submission binders in Veeva.

• Ensure that submission and correspondence files are kept current.

• Act as the local authority for regulatory inquiries from medical, supply chain, and other departments.

• Ensure compliance with regulatory requirements as well as company policies and procedures.

⛳️ Requirements

• Relevant experience in regulatory affairs within the Latin American industry.

• Understanding of contemporary trends in local and regional regulatory requirements.

• Act as a knowledgeable resource for regulatory guidance to other departments.

• Experience in engaging with Regulatory Authorities.

• Ability to facilitate interactions with International Regulatory Affairs, various internal departments, and external stakeholders, particularly submission partners.

• Bachelor’s degree in Pharmaceutical Sciences.

• Proficiency in written and spoken English.

• Knowledge of Spanish and Portuguese is considered advantageous.