Regulatory Affairs Head Andean - English version._ WHAT YOU WILL DO Also, responsible for developing submission strategies; providing guidance/advice on local country regulatory environments; assessing the impact of new and changing regulations/requirements. Maintain strong relationships with key external stakeholders such as BoH and industry associations. The role reports to the General Manager of Colombia. WHAT YOU WILL WORK ON : 1. Evaluate local business and regulatory registration requirements for investigational and marketed products, and prepare regulatory assessment reports. 2. Develop submission strategies; prepare project plans, timelines, and related project fees. Prepare project status reports for management/departments. 3. Provide strategies to management and interact with regulatory agencies to resolve related review questions. 4. Maintain a centralized archive of all regulatory files. 5. Establish a library of all applicable regulations and guidance documents. 6. Provide guidance/advice on international regulatory environments; assess the impact of new and changing regulations/requirements. 7. Participate and provide international guidance to CMC, preclinical, clinical, and marketing program teams as needed. 8. Develop strong and effective working relationships with regulatory agencies, company consultants, and partners. 9. Develop meeting materials and chair/attend meetings with regulatory agency inspections. 10. Review promotion and advertising materials. 11. Proactively participate in all activities defined according to the position and role, within the framework of the SG-SST Occupational Health and Safety Management System, seeking health and safety care, thus achieving compliance with the company's policies in this matter. WHO ARE WE LOOKING FOR : Education and Experience - College degree preferably in chemistry and/or pharmacy. - Minimum 5-7 years of experience with multinational companies in Regulatory Affairs. - Minimum 5 years managing a team and as part of a leadership team. - Proven experience managing regulatory authority INVIMA. - Desirable experience in managing consultants and authorities in Andean Countries. - Fluent verbal and written communication skills in Spanish and English. Skills & Competences : - Solid people management skills and a desire to develop team members. - Proven ability to motivate diverse teams to achieve high standards and deliver results according to objectives. - Excellent internal and external communication skills, both downward and upward. - Committed to fostering a diverse, equitable, and inclusive environment. LOCATION: Bogota, Colombia. #J-18808-Ljbffr