Associate Director, Biosurgery, Regulatory Affairs
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Chiyoda • New Jersey • United States
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Job Level
About the role
- Lead and execute robust regulatory strategies and submissions for pharmaceutical products (drugs & biologics) and medical device-related (including container closure or delivery device) in Japan, ensuring compliance with local regulations.
- Author and lead relevant end-to-end submission activities delivering project milestones and maintaining compliance with local regulations.
- Provide strong leadership and mentorship, fostering a culture of excellence and collaboration.
Requirements
- Fluency in Japanese and English is required.
- Bachelor’s degree (or equivalent) is required.
- Minimum 7 years relevant pharmaceutical/medtech industry experience is required or 5 years with an advanced degree.
- Previous experience with biologics (including regulatory submissions) is required.
- Proven track record of developing and executing global regulatory strategies that align with business deliverables is required.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategiesregulatory submissionsbiologicsproject managementcompliancepharmaceutical productsmedical devicesend-to-end submission activitiesglobal regulatory strategies
Soft skills
leadershipmentorshipcollaborationcommunication
Certifications
Bachelor's degree