Senior Regulatory Affairs Manager - LAN Cluster

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: People Leader All Job Posting Locations: Bogotá, Distrito Capital, Colombia Job Description: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. We are searching for the best talent for this Senior Regulatory Affairs Manager - LAN Cluster, based in Bogota. Purpose: The senior regulatory manager is the Head of Local Operating Company Regulatory Affairs. Provides strategic and operational leadership for all Regulatory Affairs activities across the cluster. The role shapes business and portfolio decisions by anticipating the regulatory environment, defining differentiated strategies across the product lifecycle, and aligning local priorities with regional and global objectives. The Head is accountable for securing and maintaining marketing authorizations, enabling timely launches and lifecycle opportunities, ensuring regulatory compliance and inspection readiness, and proactively managing regulatory risks and critical issues. The role serves as the senior company interface with Health Authorities and industry stakeholders, builds trusted cross-functional partnerships, influences/shapes the external regulatory environment to advance patient access and business outcomes, and leads a diverse, high-performing Regulatory Affairs organization through effective resource prioritization, capability building, succession planning, and talent development. Based on local regulations and where applicable, the Head may also serve as the legally responsible person before Health Authorities. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. We are searching for the best talent for a Customer Insights & Experience Sr Specialist position, based in São Paulo. Purpose: - The Customer Insights & Experience Sr Specialist is responsible for generating actionable customer and field force insights that support commercial decision-making, customer engagement, and business performance across multiple countries. - This role partners closely with Commercial, Marketing, Customer Engagement, and Analytics teams to transform data into meaningful recommendations, optimize field force execution, improve customer experiences, and drive adoption of performance management best practices. - The Sr Specialist acts as a key contributor in analytics initiatives, performance reporting, customer journey evaluations, and process improvements, ensuring insights are translated into tangible business actions. KEY RESPONSABILITIES: Analyze the regulatory, healthcare, political, and competitive landscape of the cluster. Translate regional priorities into a clear local plan, co-created with internal and external stakeholders. Recommend strategic priorities and options to regional leadership. Identify risks, opportunities, dependencies, and resource needs. Ensure team activities are aligned with strategic objectives. Provide local insights to inform regional decisions. Ensure operations are consistent, predictable, and compliant with applicable standards. Review performance, quality, risks, capacity, and priorities. Define clear mechanisms for accountability and escalation. Intervene directly in matters involving high risk or high impact, or those exceeding the team's authority. Eliminate processes, meetings, reports, and governance structures that consume time without adding value. Identify operational vulnerabilities and establish mechanisms for continuity, documentation, cross-training, and backup within the team. Uphold ethical and compliance standards, even under pressure. Actively contributes to the local business strategy from the perspective of regulation and timely access to innovation. Actively Integrate perspectives from Commercial, Medical Affairs, Market Access, Policy, Legal, Quality, and Supply functions. Translate technical information into clear business options. Explain the value, risks, and implications of each alternative. Establish shared objectives and reduce functional silos. Facilitate integrated decision-making, without merely acting as a meeting coordinator. Maintaining credible relationships with authorities and relevant stakeholders. Representing approved technical positions. Identifying opportunities for collaboration, reliance, convergence, or regulatory innovation. Proposing forums, coalitions, or external interventions. Actively Coordinates initiatives with Policy, Government Affairs, Medical Affairs, and other functions. Escalating reputational and political opportunities or risks. Measuring the progress and results