Regulatory Affairs jobs in United States

Job title: Regulatory Affairs Specialist (Japanese speaking)
Reference ID: 36639

Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regulatory Affairs Specialist (Japanese speaking) to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring activities across local affiliates.

You will be reporting to the Regulatory Affairs Department in Japan.

【 Responsibilities 】
‐ Handle mainly regulatory operations tasks
- Report directly to the Regulatory Affairs Department in Japan
- Coordinate regulatory submissions (new and variation) across Asia/ASEAN
- Manage regulatory documents and ensure timely submissions
- Develop regulatory strategies with cross-functional teams
- Track and monitor local affiliate regulatory activities
- Identify and resolve regulatory issues proactively

【 What you will receive 】
- AWS
- Variable Bonus (Depends on Company and Individual performance)
- Annual Leave 14 days
- Medical Leave
- Medical Benefits
- Flexible Benefits (S$1500/year)
- WFH: Once a week to be at the Office, other days WFH

【Requirements & Preferences】

(Must)
- Diploma in any discipline.
- Minimum 2 years of experience in Regulatory Affairs within Singapore's pharmaceutical industry.
- Proficiency in both written and spoken Japanese (equivalent to JLPT N1) and business-level English is required to liaise with counterparts and handle documentation.
- Proactive, self-motivated, and able to take initiative with high energy levels.

(Advantageous)
- Strong communication and negotiation skills.
- Logical thinking and sound problem-solving capabilities.
- Ability to adapt well to changes and work effectively under pressure.

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We regret that only shortlisted candidates will be notified.

Registration No.: R1659635 (Nur Haida Sakina Binte Mohd Azmi)
Recruitment Licence: 12C5051