Senior Regulatory Affairs Specialist
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: São Paulo • Brazil
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Job Level
About the role
- Provides support to the C-ROSS(MS) Product Leader and Regulatory Regional Leader for regulatory activities
- Participates in working groups for timely regional and local input into product objectives
- Advises the Regulatory team on applicable regulatory requirements and project-specific issues
- Works with regional staff and LOCs to support activities and assists in preparation for meetings with Regulatory Agencies
- Tracks dates of submissions and Regulatory Agency responses
- Provides regulatory support throughout the registration process
Requirements
- Fluent English (writing and verbal)
- Knowledge of regulatory requirements related to submissions
- Understands CTA, iCTD, and ACTD dossier component requirements
- Ability to review and contribute to the compilation of CTA, iCTD, and ACTD dossier components
- Basic understanding of clinical trials and drug development
- General knowledge of HA timelines for reviewing submissions.
Benefits
- Flexible work arrangements
- Professional development
- Health insurance
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory requirementsCTAiCTDACTDdossier componentsclinical trialsdrug developmentsubmission trackingregulatory submissions
Soft Skills
communicationadvisorycollaborationorganizational