上海市 | 1人
The US-based WuXi STA Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) team is looking for a CMC professional at an Associate level. This is an exciting opportunity to contribute to end-to-end development and commercialization of wide range of products and modalities, including small molecules, oligonucleotides, and peptides. Technical expertise in CMC is required.
• Strong oral & written communication skills in English.
• Proficiency with Microsoft Office Applications, Word, Excel, Outlook and functional systems such as ChemDraw.
• Assists Regulatory Affairs CMC team representative in authoring and reviewing of routine DMF, IND and IMPD submissions and amendments.
• Tracks project progress and organizes documents and submissions.
• Performs data verification and formatting to ensure excellence in dossier presentation.
• Performs other related duties as assigned.
• Bachelor’s degree required, with at least 2 years of pharmaceutical development experience
• Prior experience in preparing INDs, IMPDs, NDA and/or MAA submission(s) is a plus.
• Experience working on cross-functional teams and good interpersonal skills are required.
• Strong team player who is solution oriented.
• Proven ability to successfully manage projects and timelines, organize/track complex information, and prioritize accordingly.