Senior Regulatory Affairs Officer (Pharmaceutical)

Otsuka people creating new products
for better health worldwide

is our philosophy that all Otsuka family globally know that they will be highly valued and encouraged to fulfill their potentials. We provide a welcoming, friendly and inspiring work environment that nurtures their growth and passion, as an individual and as part of a team, and stimulates their creativity that make us a unique and great place to work. The pharmaceutical company with our business includes manufacturing, trading, import and export of nutrition and pharmaceutical products. Total employees: Manufacturing 700 person, Head office (Sales and Business support) 200 person.

Job Responsibilities:

1. Product Registration

• Submit registration documents and follow up until approval is obtained.
• Submit required documents to the FDA.
• Submit documents for the amendment of approved licenses.
• Provide necessary information to principals upon request.

2. Documentation

• Review registration documents, approved licenses, and related documents such as  
•   Certificates of Analysis (COA), etc.
• Submit and follow up on approval for simple promotional materials.
• Submit monthly, quarterly, half-year, and annual importation and sales reports to the FDA.
• Submit reports on restricted products (e.g., new drug) to the FDA.
• Provide additional documents for hospital bidding/tender as needed.

3. Other Responsibilities

• Coordinate with other departments regarding product registration, license amendments, promotional materials, and advertisement permissions.
• Coordinate with the marketing department and principals concerning product quality assurance.
• Verify labels and packaging materials to ensure compliance with FDA requirements for imported products.
• Verify promotional materials to ensure compliance with FDA regulations and obtain necessary approvals.

Qualifications & Competencies:

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences.
• Minimum 2 years of experience in regulatory affairs or pharmaceutical manufacturing.
• Proficient in both spoken and written English.
• Computer literate, with proficiency in Microsoft Word, Excel, and PowerPoint.
• Strong communication and problem-solving skills.
• Solid understanding of Thai FDA regulations and international regulatory requirements and processes.