Manjing Chen

As a Regulatory Project Assistant at Humphries Pharmaceutical Consulting, I have gained hands-on experience in providing regulatory interpretation and counseling, as well as assisting in the submission process for various regulatory documents. I have a solid understanding of regulatory requirements and guidelines, including FDA regulations and ICH guidelines, and I am well-versed in current good manufacturing practices (CGMPs). My experience in project management and my ability to work effectively in a team-oriented environment have allowed me to successfully support regulatory projects and ensure high-quality output.

Furthermore, my master’s degree in Biostatistics from Georgetown University has equipped me with a strong foundation in data analysis and statistical techniques. This educational background has honed my critical thinking and problem-solving skills, which are crucial in navigating regulatory challenges and making informed decisions. I am adept at reviewing CMC documents for compliance and accuracy, and I am experienced in drafting internal reports and documents to support regulatory submissions.

As a Regulatory Project Assistant at Humphries Pharmaceutical Consulting, I have gained hands-on experience in providing regulatory interpretation and counseling, as well as assisting in the submission process for various regulatory documents. I have a solid understanding of regulatory requirements and guidelines, including FDA regulations and ICH guidelines, and I am well-versed in current good manufacturing practices (CGMPs). My experience in project management and my ability to work effectively in a team-oriented environment have allowed me to successfully support regulatory projects and ensure high-quality output.

Furthermore, my master’s degree in Biostatistics from Georgetown University has equipped me with a strong foundation in data analysis and statistical techniques. This educational background has honed my critical thinking and problem-solving skills, which are crucial in navigating regulatory challenges and making informed decisions. I am adept at reviewing CMC documents for compliance and accuracy, and I am experienced in drafting internal reports and documents to support regulatory submissions.

.As a Regulatory Project Assistant at Humphries Pharmaceutical Consulting, I have gained hands-on experience in providing regulatory interpretation and counseling, as well as assisting in the submission process for various regulatory documents. I have a solid understanding of regulatory requirements and guidelines, including FDA regulations and ICH guidelines, and I am well-versed in current good manufacturing practices (CGMPs). My experience in project management and my ability to work effectively in a team-oriented environment have allowed me to successfully support regulatory projects and ensure high-quality output.

Furthermore, my master’s degree in Biostatistics from Georgetown University has equipped me with a strong foundation in data analysis and statistical techniques. This educational background has honed my critical thinking and problem-solving skills, which are crucial in navigating regulatory challenges and making informed decisions. I am adept at reviewing CMC documents for compliance and accuracy, and I am experienced in drafting internal reports and documents to support regulatory submissions.