Regulatory Affairs Manager

2 days ago

Japan, India GE Healthcare Ltd Full time ₹ 10,00,000 - ₹ 15,00,000 per year
Job Description

Summary

We are seeking a highly motivated Regulatory Affairs Manager to lead regulatory strategies and ensure compliance for pharmaceutical and medical device products. This role plays a critical part in supporting product launches, regulatory submissions, and post-market activities, while maintaining strong relationships with regulatory authorities in Japan. You will collaborate closely with cross-functional teams, global stakeholders and partner companies, providing expert guidance on regulatory requirements and contributing to the success of innovative healthcare solutions.

Regulatory Affairs Manager

Key Responsibilities
  • Lead regulatory submissions and approvals for pharmaceuticals and medical devices
  • Manage communications and consultations with regulatory authorities
  • Oversee updates to product labeling and packaging
  • Review promotional materials to ensure regulatory compliance
  • Provide regulatory insights and guidance to internal teams and global counterparts
  • Build and maintain strong relationships with regulatory agencies and suppliers
Requirements Must Have
  • Minimum 5 years of experience in Regulatory Affairs for pharmaceuticals and/or medical devices
  • Fluent Japanese and business-level English proficiency
  • Proficiency in Microsoft Office tools (Excel, Word, PowerPoint, Outlook)

/5

PCExcelWordPowerPointOutlook

Nice to Have
  • Experience working in cross-functional and cross-regional teams
  • Strong communication skills and adaptability in dynamic environments
  • Project management experience
Why Join Us?
  • Global Exposure: Collaborate with international teams, expanding your global perspective
  • Impactful Work: Contribute to the launch and compliance of life-changing healthcare products
  • Career Growth: Leverage your expertise in Regulatory Affairs to grow into leadership roles within a global organization
Additional Information
  • Relocation Assistance Provided: No
  • Locations - Location: Minato, Tokyo, Japan,

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