Regulatory Affairs Executive

WORK EXPERIENCE

• Minimum of 2–5 years’ experience in Regulatory Affairs and/or Pharmacovigilance
• Experience in pharmaceutical or multinational company is preferred
• Experience in product registration or safety reporting is an advantage

EDUCATION

• Bachelor’s degree in pharmacy or life sciences (or related field)

SKILLS AND SPECIFICATIONS

• Good English verbal and written communication skills.
• In-depth practical knowledge of the applicable regulations and guidance.
• Proactive and highly committed to supporting and delivering results.
• High organized and self-disciplined.
• High sense of ownership and accountability for achievement.
• Good at communicating with internal and external stakeholders.

Meal, Transportation Allowances 

Private Health Insurance 

Bonus

POSITION SUMMARY

The RA Executive is responsible for supporting regulatory activities for assigned products to ensure compliance with local regulations and company requirements.

In addition, as Celltrion Vietnam operates as the Market Authorization Holder (MAH), the role will also support local Pharmacovigilance (PV) activities in accordance with Vietnamese regulatory requirements. This includes assisting in adverse event (AE) handling, safety data management, and coordination with HQ PV to ensure timely reporting and compliance.

The position requires close collaboration with internal teams, HQ, and external stakeholders to support product registration, maintenance, and safe product lifecycle management in Vietnam.

KEY ROLES AND RESPONSIBILITIES

1) Regulatory Affairs (RA)

• Support preparation, submission, and lifecycle management of regulatory dossiers for assigned products
• Track and follow up on ongoing submissions with the Drug Administration of Vietnam (DAV)
• Support development and execution of regulatory strategies under guidance of RA&MA Head
• Maintain up-to-date knowledge of local regulatory requirements and guidelines
• Prepare and review regulatory documents to ensure compliance with local regulations
• Provide regulatory support to internal teams (Commercial, Medical, etc.)
• Support communication with regulatory authorities and business partners as needed

2) Pharmacovigilance (PV)

• Support local PV activities in compliance with Vietnamese regulations and global PV requirements
• Collect, process, and report adverse events (AEs) and product quality complaints in a timely manner
• Coordinate with HQ PV team and relevant stakeholders for case processing and safety reporting
• Maintain PV documentation and ensure proper record keeping
• Support implementation and maintenance of local PV system and SOPs
• Assist in audits and inspections related to PV activities
• Ensure compliance with SDEA and local safety reporting obligations