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 of external initiatives.
• Assess team capabilities and recommend or implement development, mobility, and succession actions to address current and future priorities.
• Define roles, expectations, decision rights, and accountability.
• Develop successors for critical positions.
• Delegate genuine ownership, not just tasks.
• Provide direct, timely, and development-oriented feedback.
• Create cross-functional, regional, and global experiences.
• Promote mobility, cross-training, and exposure to the full business cycle.
• Recognize contributions and address performance or capability gaps early on.
• Foster inclusion, psychological safety, and well-being within a high-performance culture.
• Balance speed, evidence, compliance, reputation, and impact.
• Take calculated risks within organizational principles.
• Prevent the pursuit of perfect information from stalling execution.
• Make assumptions, alternatives, and decision criteria explicit.
• Escalate issues with a recommendation.
• Remain accountable for the outcome, even when multiple functions are involved
• Question low-value processes.
• Propose innovative solutions.
• Execute local pilots.
• Use data, automation, and artificial intelligence responsibly.
• Measure results and document learnings.
• Scale successful solutions for regional evaluation.
• Promote learning and adoption within the team.
• Communicate regional priorities and decisions to the local team.
• Escalate country-level risks, opportunities, and insights.
• Represent the regulatory perspective in local governance.
• Ensure consistency of messaging.
• Share best practices across countries.
• Participate in meetings with external stakeholders based on previously aligned positions.
• Contributes to the construction of integrated product strategies, ensuring that regulatory, operational, supply and access implications are considered from early stages.
• Promote collaboration between Regulatory Affairs groups, and other relevant stakeholders, generating clarity on common objectives, priorities, dependencies, decisions and responsibilities.
• Maintain a comprehensive view of the portfolio to identify conflicting priorities, accumulated risks, critical dependencies and potential impacts to patients, business and local operation.
• Timely raise issues that may compromise approvals, compliance, supply, product continuity or local operation.
• Coordinate with cross-functional teams the construction and implementation of mitigation strategies and plans for identified risks.
• Escalate situations that exceed the authority, capacity or resources of the country or cluster, or that may generate a regional, reputational, financial, legal, compliance or patient impact, presenting options and a clear recommendation.
• Follow up on agreed decisions, commitments and mitigation plans, ensuring accountability, communication, documentation and timely closure.

KNOWLEDGE, EDUCATION, EXPERIENCE:

    

• Minimum: University degree in Life sciences (e.g., Chemistry, Biology); Pharmacists preferred.
• Extensive Regulatory Affairs experience (7+ years) at both operational and strategic level
• Working knowledge of local regulations and guidelines related to drug development and registration.
• Hands-on experience in pharmaceutical product registration & approval, focused in innovative products & shaping strategies  
• Experience in Health Authority interactions. Ability to act as company spokesperson with Health Authorities. (head)
• Experience in QA/QC
• Proficiency in written and oral English
  

 

 

Required Skills:

 

 

Preferred Skills:

Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Managing Managers, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking