Johnson & Johnson
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Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Buenos Aires, Argentina, Lima, Peru, Mexico City, Mexico, São Paulo, Brazil
Job Description:
Johnson & Johnson is hiring for a Regulatory Affairs Analyst to join our team
Job Summary:
Supports the execution of regulatory planning and operational activities across LATAM for Electrophysiology (EP) and Neurovascular (NV) portfolios. Supports dossier delivery to Local Operating Companies (LoCs), contributes to data-driven decision-making, and drives process standardization to enable efficient lifecycle management (LCM) and new product introductions (NPI).
Key Responsibilities:
Regulatory Planning & Execution:
- Supports the execution of regional regulatory plans for LCM and NPI projects.
- Supports regulatory actions (RAAs) ensuring alignment with strategy timelines and country requirements.
- Monitors execution status, identifies risks, and escalates deviations to ensure timely delivery.
Dossier Delivery & Documentation Management:
- Execute the preparation and delivery of regulatory dossiers to LoCs ensuring completeness and compliance with local requirements.
- Tracks dossier submission timelines and ensures alignment with regulatory action plans and market needs.
- Supports document management activities, including version control, repository updates (e.g., SharePoint/Windchill), and documentation readiness.
- Acts as a liaison between regional teams and LoCs to ensure clarity on dossier requirements and timely delivery.
Strategy & Operations Support:
- Contributes to planning and forecasting activities, ensuring high-quality and reliable data.
- Supports prioritization of regulatory activities based on business impact and capacity.
- Maintains regional trackers, dashboards, and planning tools.
Data, Metrics & Reporting:
- Consolidates and analyzes regulatory performance metrics (execution, backlog, timelines, dossier delivery status).
- Provides insights to support decision-making and leadership discussions.
- Ensures visibility and transparency of regulatory workload across LATAM.
Process Optimization:
- Identifies opportunities to improve planning, dossier delivery, and operational processes.
- Supports standardization and implementation of best practices across clusters.
- Participates in continuous improvement and transformation initiatives.
Stakeholder Management:
- Collaborates with local RA teams, Strategy Owners, and cross-functional partners.
- Facilitates alignment between regional and local teams for effective execution.
- Supports communication and follow-up of regulatory activities and dossier deliveries across stakeholders.
Scope & Impact:
- Supports regional execution of regulatory strategies across EP & NV portfolios.
- Ensures timely and compliant dossier delivery to LoCs, enabling submissions and product lifecycle continuity.
- Contributes to improved planning accuracy, operational efficiency, and delivery performance.
Qualifications:
Education:
- Bachelor’s degree in Pharmacy, Engineering, Life Sciences, or related field.
- Advanced or intermediate Skills in English/ Spanish is preferred.
Experience:
- 0–2 years of experience in Regulatory Affairs or related field.
- Exposure to regulatory documentation or dossier management is a plus.
Knowledge & Skills:
- Strong analytical and problem-solving skills.
- High attention to detail and process orientation.
- Ability to manage multiple priorities and meet deadlines.
- Effective communication and collaboration skills.
- Proficiency in Excel; data visualization tools (e.g., Power BI) is a plus.
Leadership Expectations (C.E.O Model):
- Connect: Builds collaborative relationships with cross-functional and regional stakeholders.
- Shape: Uses data and insights to identify improvement opportunities.
- Deliver: Ensures accurate and timely execution of assigned activities.
Required Skills:
Preferred Skills: