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 jnj.com.
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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Buenos Aires, Argentina, Lima, Peru, Mexico City, Mexico, São Paulo, BrazilJob 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:
