Job Brief: 

• Prepare and maintain product registration dossiers in eCTD format for EU and US regulatory submissions.
• Coordinate with clients, manufacturers, and subject matter experts to gather and manage the necessary data for registration.
• Provide expert advice to internal and external stakeholders on regulatory matters, including responses to health authority queries.
• Represent the regulatory function in cross-functional project teams, ensuring compliance requirements are integrated into product development plans.
• Monitor and implement changes in regulatory guidelines and ensure their application in current processes (Regulatory Intelligence).
• Oversee regulatory changes and manage the lifecycle of products to ensure ongoing compliance.
• Lead initiatives to enhance regulatory processes and contribute to continuous improvement within the department.
• Collaborate closely with Quality, Operations, and other departments to maintain compliance and streamline workflows.
• Proactively propose and implement regulatory strategies or solutions to address challenges related to projects and products.
• Review and evaluate change control requests, ensuring timely notification of supporting data for variations.
• Ensure accurate and timely submission of product variations through client coordination.
• Support the company during inspections from health authorities by providing regulatory expertise. 

• Bachelor’s degree in Health Sciences (Pharmacy, Chemistry, or a related field).
• Proven experience in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of eCTD dossier preparation and submission processes for the EU and US markets.
• Proficiency in spoken and written Spanish and English.
• Excellent understanding of international regulatory standards (ICH, EU, US).
• Strong project management and organizational skills, with the ability to manage multiple priorities effectively.
• Proactive mindset with the ability to propose solutions and strategies to complex regulatory challenges.
• Collaborative approach with strong interpersonal skills to work across teams and departments.