Regulatory Affairs Sr. Specialist We're changing the way we work at Bayer - for higher productivity, faster innovation, and better results. This is what our new approach to working called Dynamic Shared Ownership (DSO) means for you in your new role: TASKS AND RESPONSIBILITIES - Ensure timely submission of NDA applications in each PACA country according to timelines in close coordination with operational specialists, local consultants, and the country AR business partner to contribute to business objectives. - Determine regulatory strategy for achieving earliest approval with appropriate labeling, in line with business objectives, considering complex regional regulatory environment. - Be accountable for lifecycle management of specific Therapeutic Area portfolio of products, ensuring regulatory compliance to support PACA business continuity, mitigate risk, and ensure marketed drugs conform to local regulations. - Develop and implement regulatory strategies to support lifecycle activities, such as submissions, renewals, variations, deviations, and amendments. - Prepare dossiers for submissions and amendments, ensure KPIs are achieved, and lead/support operational excellence projects; maintain database updates. - Ensure transparent, timely, and efficient communication with PACA Head, Business Partners, Therapeutic Areas, and the business. - Support Colombia RA operations to ensure planning, compliance, execution, control, and risk management, supporting all PACA processes assigned. WHO YOU ARE Pharmacist or equivalent; MBA degree is desirable. Minimum of 3 years of proven experience managing NDA submissions in Colombia; at least 5 years supporting Colombia operations; experience with RA in CAC countries and managing lifecycle processes for pharmaceuticals. Knowledge of regulatory environment, procedures, policies, and guidelines of Colombia, OMS, OPS, and ICH; understanding of international regulations (EMA, FDA, ICH, PAHO-OMS). Nice to have knowledge of RA legislation in Central America, Caribbean, and Andean regions. Proven analytical, negotiation, influencing, and communication skills; ability to manage ambiguity and multiple projects. Strong business acumen, customer focus, and ability to develop regulatory strategies and solutions. Flexibility to operate in crisis environments when necessary. WHAT WE OFFER YOU Full-time employment contract. Wide range of development opportunities. Attractive benefits package. Good working conditions and a comfortable environment. Hybrid working model. Bayer believes in diversity, equity, and inclusion. We aim to create an environment where everyone feels authentic, respected, and valued. We seek diversity to enable our people to bring their full potential and to inspire others. Our success depends on leveraging our diverse capabilities to lead cultural transformation and positively impact society. Candidates meeting the job requirements will be considered for employment regardless of disability, race, color, religion, sex, age, sexual orientation, gender identity, or unemployment status.