Senior Regulatory Affairs and Quality Assurance Specialist

About this Position

The Senior Regulatory Affairs and Quality Assurance Specialist (Sr. RA & QA Specialist) is responsible for executing regulatory and quality assurance activities to ensure compliance with business objectives and legal requirements, reporting to the Regulatory Affairs Manager.

What you’ll do

Regulatory Activities:

• Prepare, submit, and follow up on applications for notification receipts (for cosmetics) and other licenses, with a preference for candidates experienced in Product Information Files (PIF), food supplements, hazardous substances, or medical devices.

• Complete renewal and new applications for imported and storage licenses to facilitate business launches and ensure continuity while compiling, updating, and maintaining regulatory databases and internal master data systems.

• Review, comment on, and submit documentation to obtain results from the Thai FDA and Thai Industrial Standards Institute (TISI), as well as promotional materials, claims, and labelling to ensure compliance with applicable regulations and policies.

• Maintain and update existing and emerging regulations, standards, and guidelines for cross-functional and APAC teams, while developing regulatory strategies and communicating effectively with these teams.

• Prepare responses to internal and customer requests, including product data and regulatory affairs statements, and oversee the collection and preparation of samples as requested by authorities.

 Quality Assurance Activities:

• Analyze product complaints according to internal guidelines, monitor the complaint process, and summarize complaint case reports while serving as the primary contact for Adverse Event (AE) reports, managing the internal reporting system and submitting AE reports to the Thai FDA as needed.

• Participate in and prepare documentation for internal or external audits conducted by the Thai FDA or customers, and conduct QA training for employees on procedures such as recalls, complaints, AE reporting, and future regulations (e.g., Good Distribution Practice).

• Coordinate and update QA technical files, including Standard Operating Procedures (SOPs) and work instructions, in line with new regulations and internal audits, and contribute to recall management activities as necessary.

• Perform any other related tasks as assigned.

What makes you a good fit

• Bachelor’s degree or higher in Pharmaceutical Science, Cosmetic Sciences, or a related field, with strong knowledge of cosmetics regulations and pharmaceutical ingredients.

• A minimum of 3-5 years of experience in Regulatory Affairs and/or Quality Assurance within the cosmetics or pharmaceutical industry, with a preference for experience in food supplements, hazardous substances, or medical devices.

• Proficient in MS Office (Word, PowerPoint, Excel) and adaptable to change, demonstrating proactive problem-solving skills and sound judgment.

• Strong communication and negotiation skills in both English and Thai, with a sense of urgency and accountability.

• Detail-oriented with a meticulous approach to accuracy, excellent multitasking abilities, teamwork skills, and organizational capabilities.

Shiseido (Thailand) Co., Ltd
8 T-One Building 23rd-24th Floor, Soi Sukhumvit 40, Sukhumvit Road
Phra Khanong Sub-district, Khlong Toei District, Bangkok 10110 
Tel : 0-2032-8300 ext. 705, 709