Regulatory Affairs Specialist

2 weeks ago


Singapore Reeracoen Singapore Pte Ltd Full time

Job title: Regulatory Affairs Specialist
Reference ID: 36639

Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regulatory Affairs Specialist 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 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.


We regret that only shortlisted candidates will be notified.
Registration No.: R Cathy Chau )
Recruitment Licence: 12C5051

#J-18808-Ljbffr

  • Singapore Ethos BeathChapman Full time

    **Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-179384 **Contact** Roselle Cuntapay **Posted** about 3 hours ago - Currently recruiting for a Regulatory Affairs Specialist for a small Medical Device business. Their product is currently in a couple of markets (and doing well) but they are...


  • Singapore ALCOTECH PTE. LTD. Full time

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...


  • Singapore ALCOTECH PTE. LTD. Full time

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...


  • Singapore beBeeRegulatory Full time $80,000 - $140,000

    Job Title: Regulatory Affairs Specialist">This is a unique opportunity to leverage your expertise in regulatory affairs and medical writing to drive business success.The ideal candidate will possess strong analytical skills, excellent communication abilities, and the ability to work effectively in a collaborative environment.">Responsibilities:">Develop...


  • Singapore Johnson & Johnson Full time

    Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of...


  • Singapore ALCOTECH PTE. LTD. Full time

    **Alcotech Pte Ltd**specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. **Role Overview**: **Key Responsibilities**: - Prepare, review, and submit medical device registration dossiers...


  • Singapore MERIT MEDICAL SINGAPORE PTE. LTD. Full time

    **PURPOSE OF JOB** Subject matter expert in determining the current regulatory requirements and strategies for Merit Medical Singapore design control projects. Prepare documents and /or submission required to obtain clearance or approval from government agencies for commercial distribution of Merit’s Medical Devices. Key government agencies with direct...


  • Singapore beBeeRegulatory Full time

    Regulatory Affairs Specialist RoleWe are seeking a skilled and detail-oriented Regulatory Affairs Specialist to support our regulatory activities.This role will involve assisting with the submission of applications and variations for clinical trials and marketing authorisation across all pipelines.Main Responsibilities:Submission Support: Assist with the...


  • Singapore Marina Bay Sands Full time

    Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands 2 weeks ago Be among the first 25 applicants Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands Get AI-powered advice on this job and more exclusive features. LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HEREBe part of our diverse and...


  • Singapore beBeeRegulatory Full time $70,000 - $101,000

    Regulatory Affairs Specialist Role OverviewThis is an exciting opportunity for a highly skilled Regulatory Affairs Specialist to join our organization. As a key member of the regulatory team, you will play a pivotal role in ensuring compliance with regulatory requirements and facilitating the registration of products in designated countries.