Regulatory Affairs Senior Manager Jobs

Randstad

Location:
Japan, Tokyo

Category:
Pharmacy

Contract Type:
Not provided

Salary:

8000000.00 - 12000000.00 JPY / Year

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Job Description:

Lead regulatory strategies and submissions for innovative oncology products in a dynamic and collaborative environment. Develop and implement regulatory strategies for innovative oncology products in the Japanese market. Lead cross-functional teams, manage submissions to the PMDA, and ensure compliance with all relevant regulations.

Job Responsibility:

Lead the development and execution of regulatory strategies for new and existing products
Manage the preparation and submission of regulatory documents to the PMDA
Collaborate with cross-functional teams to ensure alignment on regulatory requirements
Monitor and interpret changes in regulatory landscape
Lead communication with PMDA/MHLW to ensure timely approvals
Identify and mitigate regulatory risks

Requirements:

Bachelor's degree or higher in life sciences, engineering, or a related field
8+ years of experience in regulatory affairs, with at least 3 years in IVD, genetic testing, precision medicine, or oncology
Proven experience in managing regulatory submissions to the PMDA
Strong understanding of Japanese regulatory requirements for medical devices and IVDs
Excellent communication skills in Japanese and English
Strong organizational and project management skills
Experience leading and mentoring teams
Experience with QMS and design control
Familiarity with genomic/molecular technologies
Experience negotiating with regulatory authorities

What we offer:

Health insurance
Employee pension insurance
Employment insurance
Saturdays off
Sundays off
Holidays off
Bonus
RSU

Additional Information:

Job Posted:
November 30, 2025

Expiration:
May 27, 2026

Employment Type:

Fulltime

Work Type:

Hybrid work

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Regulatory Affairs Senior Manager

Randstad

Location:Japan, Tokyo

Category:Pharmacy

Contract Type:Not provided