International Registration Specialist简历模板

• Systematically studied pharmacy major courses, including medicinal chemistry, pharmaceutics, pharmacology, etc., laying a solid professional foundation for international registration work. • Actively participated in academic exchange activities organized by the school, broadened professional horizons, and cultivated good academic literacy.

• Responsible for the registration and declaration of the company's drugs in the European and American markets, including material preparation, communication with local regulatory agencies, etc. Successfully completed the registration and declaration of [X] drugs, among which [X] drugs were successfully approved for marketing, making an important contribution to the company's expansion of the international market. • Conducted in - depth research on drug registration regulations and technical requirements in Europe and America, timely grasped regulatory dynamics, and provided professional suggestions for the company's product R & D and registration strategies. • Closely cooperated with R & D, production, quality and other departments to ensure the accuracy and completeness of registration materials. Coordinated and solved problems that occurred during the registration process to promote the smooth progress of the project.

• Led the registration work of the company's key products in the EU and the United States, led the team to formulate registration strategies and plans. By optimizing the registration process, shortened the registration cycle by [X]%, saving a lot of time and cost for the company. • Established and maintained good relationships with regulatory agencies in Europe and America, organized participation in international industry conferences and seminars, and enhanced the company's popularity and influence in the international market. • Responsible for training and guiding newly hired registration specialists to improve the overall business level of the team. Organized internal regulatory training and experience sharing meetings to promote knowledge sharing and team collaboration.

• As the project leader, responsible for the registration and declaration of the company's innovative drug [Drug Name] in the EU. • Organized cross - departmental teams (R & D, clinical, quality, etc.) to prepare and review registration materials to ensure that the materials meet EU regulatory requirements. • Conducted multiple communications and exchanges with EU regulatory agencies to timely solve problems raised during the review process. • Finally, the drug successfully passed the EU registration review and obtained the marketing license, taking an important step for the company's innovative drug to enter the international market.

• Participated in the company's generic drug [Drug Name] registration project in the United States, responsible for the collation and submission of registration materials. • Studied FDA regulations and technical guidelines in the United States to ensure that the materials meet the requirements. • Cooperated with local US agencies to track the registration progress and timely feedback information. • The drug successfully obtained the FDA approval number in the United States, providing strong support for the company's generic drug business to expand the US market.