1. Responsibilities and Job Requirements:
*Responsible for reviewing Finished AND and ANDA CMC documents to ensure compliance with international and regional regulatory standards.
*Coordinate with internal teams to ensure product compliance and registration progress.
*Provide technical and regulatory expertise, assisting in resolving product development and regulatory issues.
*Familiar with regulatory requirements in various countries to ensure submitted documents adhere to local regulations.
*Participate in cross-functional collaboration during the review process to ensure effective project execution.
*Manage the team, provide guidance and professional training, ensuring optimal team performance.
2. Qualifications and Skills Required:
*Bachelor's degree or above in Pharmacy, Chemistry, or a related field.
*Minimum of 5 years of experience in drug review, particularly in the field of raw materials.
*Familiarity with international drug regulatory requirements, including ICH, FDA, EMA, etc.
*Excellent communication and leadership skills, with the ability to effectively manage teams and coordinate cooperation.
*Strong problem-solving and decision-making abilities, capable of addressing complex regulatory challenges.
*Fluent spoken and written English communication skills.
1. 職責與職位要求:
*負責審查NDA/ ANDA製劑相關文件,確保其符合國際和地區監管標準
*與內部團隊協調,確保產品的合規性和註冊進度
*提供技術和法規方面的專業建議,協助解決產品開發和監管問題
*熟悉各國監管要求,確保提交的文件遵守各地的法規
*參與審查過程中的跨部門協作,確保項目的有效執行
*管理團隊,提供指導和專業培訓,確保成員發揮最佳水平
2. 資格與技能要求:
*擁有藥學、化學或相關領域的學士或以上學位
*至少有5年以上的藥品審查經驗,特別是在原料藥領域
*熟悉國際藥品監管要求,包括ICH、FDA、EMA等
*優秀的溝通和領導能力,能夠有效管理團隊和協調合作
*強大的問題解決和決策能力,能夠應對複雜的監管挑戰
*流利的英語口語和書面表達能力