RA CMC Associate Director


Your new company

Your new role
• Lead preparation of IND, NDA submission CMC dossier preparation, review and finalization • Act as the small molecule CMC contact person for submitted dossier, and directly interact with regulatory agencies or health authority on CMC related issues. • Lead activities of post approval changes in CMC areas • Lead interactions with health authorities in all levels • Provide regulatory CMC guidance to the project teams to ensure development activities are compliant with relevant guidelines and governmental regulations • Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development with focus on late-stage development and post-approval regulatory support for all GMP related activities (Change control and deviation regulatory evaluation, etc.) • Ensure that the content and format of regulatory submissions comply with applicable regulations and guidelines. Communicate and collaborate with internal stakeholders.

What you'll need to succeed
1 . The candidate must demonstrate scientific understanding to the principle of small molecule CMC 2 . Is familiar to the national level or state level regulatory guidance and requirements, including CDE, NMPA. 3 . Excellent verbal and written communication skills 4 . Demonstrate leadership skills 5 . Be a team player 6 . Creative problem solving and strategizing abilities 7 . Minimum BS degree in a scientific discipline. Advanced degree and RAC certification are pluses

What you'll get in return

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1230999


Life Sciences
31 Jan 2023


请联系负责该职位的专业顾问 Lennie Wang, , 地址位于 Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)

电话号码: +8602123229787