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Regulatory Affairs Analyst
Johnson & JohnsonRegulatory Affairs Analyst supporting regulatory planning and operational activities across LATAM for Electrophysiology and Neurovascular portfolios. Ensuring timely and compliant dossier delivery to Local Operating Companies.
About the role
Key responsibilities & impact- 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.
- Monitors execution status, identifies risks, and escalates deviations to ensure timely delivery.
- Executes 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.
- Identifies opportunities to improve planning, dossier delivery, and operational processes.
- Collaborates with local RA teams and cross-functional partners, maintaining regional trackers, dashboards, and planning tools.
Requirements
What you’ll need- Bachelor’s degree in Pharmacy, Engineering, Life Sciences, or related field
- 0–2 years of experience in Regulatory Affairs or related field
- Advanced or intermediate Skills in English/ Spanish
- Strong analytical and problem-solving skills
- High attention to detail and process orientation
- Ability to manage multiple priorities and meet deadlines
- Proficiency in Excel; data visualization tools (e.g., Power BI) is a plus.
Benefits
Comp & perks- Inclusive work environment
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory PlanningDossier DeliveryProcess StandardizationRisk IdentificationCompliance Monitoring
Soft Skills
Analytical SkillsProblem-Solving SkillsAttention to DetailProcess OrientationTime Management