SY11407_醫藥法規主管(課/理級)Regulatory Affairs

1. Responsibilities and Job Requirements: *Responsible for reviewing Finished NDA 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. *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 *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