Regulatory Affairs Coordinator Apply locations Bogotá Time type Full time Posted on Posted 3 Days Ago Job requisition id JR014979 Company Overview Galderma, with a unique legacy in dermatology and decades of cutting-edge innovation, is a leading emerging player in the dermatology category, present in approximately 90 countries. We offer an innovative portfolio based on science, including premium flagship brands and services that cover the entire spectrum of the rapidly growing dermatology market through Injectable Aesthetics, Dermatological Care, and Therapeutic Dermatology. Since our founding in 1981, we have dedicated ourselves to the largest organ of the human body, the skin, fulfilling individual needs with superior results in partnership with healthcare professionals. We understand that the skin we live in shapes our lives, and we are advancing dermatology for every skin story. Our Values We seek results-oriented individuals who embrace learning and bring positive energy. Candidates should combine initiative with teamwork and collaboration. Above all, they should be passionate about making a meaningful impact on consumers, patients, and healthcare professionals. We aim to empower our employees and promote personal growth while meeting current and future business needs. We value diversity and respect the dignity, privacy, and rights of every employee. Opportunity At Galderma, we actively motivate our teams to believe in our ambitious goal of becoming the leading dermatology company worldwide. Joining us offers the chance to acquire new, challenging work experiences and create a unique impact. Job Objective Ensure compliance with local regulatory requirements for dermatological products, including medicines and medical devices, by coordinating registrations, renewals, and post-marketing surveillance activities. This role requires close collaboration with multidisciplinary teams and regulatory authorities to manage regulatory processes in Colombia effectively. 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. Profile - 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. Skills - Analytical skills and attention to detail. - Knowledge of regulatory standards and good practices (GMP, BPL, BPD). - Management of documentation and regulatory compliance. - Project planning and execution. - Data analysis and preparation of executive reports. - Effective communication and leadership in supervisory activities. - Collaboration with internal and external teams. We Offer Opportunities to grow, learn, and make a direct impact on the business. We look for passionate and committed individuals to do something meaningful for health and well-being. Join us and be part of dermatological innovation! About Us Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. #J-18808-Ljbffr