Live opening · Posted 6 days ago

Regulatory Affairs Project Manager

Yochana · Washington, United States (Remote)
Linkedin Yes
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At a glance

The key details from the original listing.

Posted 6 days ago
CompanyYochana
LocationWashington, United States (Remote)
Work modeYes
SourceLinkedin
Listed6 days ago

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About the role

Description supplied by the original job listing.

🚨 Hiring: Global Regulatory Affairs Specialist / Manager
We are looking for an experienced Global Regulatory Affairs professional to support product registrations and regulatory lifecycle activities across international markets.
🔑 Top 4 Must-Have Skills
✅ 8+ years of Global Regulatory Affairs experience
✅ Global product registrations, re-registrations & renewals
✅ Regulatory dossier compilation & submission management
✅ LATAM regulatory experience – preferably INVIMA
📌 Key Responsibilities
• Lead global registrations, renewals, re-registrations and lifecycle management
• Compile and manage regulatory dossiers and submissions
• Handle variations, amendments, deficiencies and regulatory queries
• Coordinate with R&D, Quality, Manufacturing, Supply Chain, Marketing, Legal and global affiliates
• Manage regulatory timelines, milestones, risks and launch readiness
• Maintain regulatory databases, submission trackers and document repositories
• Support remediation, gap closure and compliance-driven market continuity programs
• Serve as a key regulatory contact for global stakeholders and health authorities
🎓 Requirements
• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, Regulatory Affairs or related field
• 8+ years of Regulatory Affairs experience in healthcare, consumer healthcare, oral care, cosmetics, medical devices or related industries
• Proven experience managing global registrations and regulatory lifecycle projects
• Experience with INVIMA and other LATAM regulatory authorities is highly preferred
• Strong project management, stakeholder management and cross-functional collaboration skills

Work arrangement
Yes

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