Required Attributes :Bachelor/ master’s degree in a related field (Pharmacy or Chemistry); Diploma in Regulatory Affairs with 5- 10 years Proven experience in regulatory affairs, specifically with US, EU, UK, and Emerging markets. In-depth knowledge of ICH guidelines, ASEAN CTD requirements, and eCTD publishing. Hands-on experience with regulatory document preparation and review. Strong understanding of QbD principles and ability to analyze trend data. Deep understanding of international regulations (e.g., FDA, EMA, ICH guidelines, Keeping up-to-date with changes in regulations and ensuring compliance. Proficiency in preparing, reviewing, and submitting regulatory documents. Ensuring all necessary documentation for product approval is in place, complete, and accurate
experience
10 ... Required Attributes :Bachelor/ master’s degree in a related field (Pharmacy or Chemistry); Diploma in Regulatory Affairs with 5- 10 years Proven experience in regulatory affairs, specifically with US, EU, UK, and Emerging markets. In-depth knowledge of ICH guidelines, ASEAN CTD requirements, and eCTD publishing. Hands-on experience with regulatory document preparation and review. Strong understanding of QbD principles and ability to analyze trend data. Deep understanding of international regulations (e.g., FDA, EMA, ICH guidelines, Keeping up-to-date with changes in regulations and ensuring compliance. Proficiency in preparing, reviewing, and submitting regulatory documents. Ensuring all necessary documentation for product approval is in place, complete, and accurate
experience
10 
