Regulatory Affairs Coordinator Job Details This role is responsible for ensuring compliance with local regulatory requirements for dermatological products, including medicines and medical devices. Key Responsibilities 1. Execute regulatory strategies for the registration and maintenance of medicines and medical devices in Colombia. 2. Ensure compliance with regulatory requirements in technical documentation, promotional materials, and safety updates. 3. Prepare and submit regulatory dossiers for product registrations, renewals, and variations in accordance with local regulations. 4. Maintain a controlled documentation system complying with local and international regulatory standards. 5. Lead a culture of compliance within the regulatory area. 6. Collaborate with multidisciplinary teams and stakeholders to ensure efficient regulatory processes. 7. Interpret and apply global and local regulatory standards across all processes. 8. Act as a liaison with regulatory authorities to respond to inquiries and provide additional information as needed. 9. Supervise and manage post-marketing surveillance activities. 10. Ensure accurate and timely maintenance of regulatory databases and documentation. 11. Support the development and implementation of regulatory strategies to facilitate product approvals. Requirements - Professional degree in Pharmacy. - At least 7 years of experience in regulatory affairs for pharmaceutical products and medical devices. Experience in biological products registration. - Deep knowledge of current health regulations in Colombia and experience in local and international regulatory processes, as well as good practices (GMP, BPL, BPD). - Experience in managing technical documentation and regulatory compliance. - Proficiency in English, both written and spoken.