Regulatory Project Associate (FDA Regulatory Consulting)
Full time
at MY CO2 Sdn Bhd
in
Malaysia
Posted on January 13, 2025
Job details
Regulatory Project Associate (FDA Regulatory Consulting)
Overview: We are seeking a motivated and detail-oriented Regulatory Project Associate to assist our team in supporting dietary supplement ingredient companies, traditional Chinese medicine enterprises, and food innovation companies in entering the global market. This role is ideal for fresh graduates passionate about regulatory compliance, technical writing, and cross-cultural collaboration. Responsibilities:- Assist the project managers/directors with client communication and development of application plans for U.S. FDA's GRAS and NDI, as well as EU Novel Food applications.
- Participate in client communication during the execution phase to ensure seamless project progress.
- Draft application documents, guide required test analyses, and assist with GMP compliance reviews.
- Support article publication processes and ensure alignment with regulatory requirements.
- Education: Bachelor's degree in microbiology, biochemistry, synthetic biology, fermentation, or food technology. Other relevant backgrounds are also welcome to apply.
- Language Skills: Proficiency in reading and writing in both English and Chinese.
- Strong logical thinking, a proactive attitude, and excellent learning ability.
- Exposure to academic paper writing or experience with footnote software is a plus.
- Willingness to travel to China as required.
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