Regulatory Affairs Specialist

**At Elanco (NYSE: ELAN) - it all starts with animals** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals, people, the planet and our enterprise.** **At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.** **Making animals’ lives better makes life better - join our team today** Ubicación: Santiago, Chile Tipo de trabajo: Híbrido: 3 dias of / 2 dias casa **Position Title**: Regulatory Affairs Specialist **Supervisor Title**: Manager, Regulatory Affairs Southern Cone **Job Function**:Regulatory (Senior Associate-R&D) **Position Type**: _Full Time _ **Location**: _Santiago, Chile _ **Position Description**: The Regulatory Affairs Specialist supports new product registrations and license updates for existing products and establishments. They also support the regulatory review of promotional materials, may act as the Affiliate Labeling Responsible Person, and provide support for affiliate pharmacovigilance (PV) activities and responsibilities as needed. This position requires collaboration with stakeholders and other functional areas within the organization to ensure Elanco's compliance with internal procedures, systems, and local requirements. **Functions and Responsibilities**: This position requires interaction with Regulatory Affairs Leaders to align specific functions and responsibilities with the position description and maintain consistent and clear communication among all involved parties. **Key Leadership Skills**: - Strong relationship-building skills to work effectively and flexibly within and across Elanco teams to achieve overall regulatory deliverables. - Foster a positive work environment aligned with company culture and a "Play to Win" mentality. - Challenge and accept challenges to deliver innovative technical solutions and foster an innovative culture. - Identify and utilize methods to deliver individual objectives with high quality, timeliness, and cost-effectiveness. - Strong problem-solving skills to proactively propose solutions for challenging situations. **Key Technical Skills**: - Understand regulatory requirements and contribute to regulatory discussions. - Expertise in dossier preparation. - Strong knowledge of CMC and clinical studies. - Attention to detail. - Coordinate and/or execute regulatory tasks with various stakeholders and ensure progress according to the project plan. **Minimum Qualification (education, experience and/or training, required certifications)**: - Education: Bachelor's degree in Veterinary Medicine or Pharmacy. - Language Requirements: Fluency in Spanish and English. **Experience**: - Understanding of the animal health and pharmaceutical industries. - At least three years of demonstrated experience in regulatory affairs. **Other Information**: - Travel may be required. Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status