>>>Location：Shanghai
【Responsibilities】
·Reporting to the EVP, who is in charge of Product development (CMC, IP and Regulatory Affairs). The primary responsibilities is to provide leadership to ensure drug products for clinical studies, and commercialization, and support CMC dossier preparation and regulatory submissions, both IND and NDA for IMPACT.
·Ensures drug products for clinical studies, both for early clinical development (IND filing, phase I) and later clinical development (NDA filing, phase II/III), and support seamless filing of CMC Dossiers for assigned projects in development for clinical studies, registration and approval, emphasizing scientific content and quality consistent with current & evolving regulatory requirements and expectations in China. The responsibility may also include CMC aspects of dossiers for life cycle management.
·Participates in CMC project teams in China to ensure high quality and timely deliverables of drug products for clinical studies, and support CMC dossier projects according to plan in collaboration with partners.
·Builds and strengthens relationships with local and global partners.
·Proactively alerts Leadership Team regarding CMC problems with regards to drug products, and dossier content before they become issues.
·Ensures drug products delivered on time without CMC issues that would otherwise slow down clinical progress.
·Avoidance of CMC issues holding up clinical progression of the R&D portfolio.
【Qualification】
·Master/PhD degree with background in chemistry, pharmaceutical development . Preferred with training and experience in formulation development..
·4-5 more years of pharmaceutical R&D development experience within pharmaceutical /biotech industry, oncology drug development is plus.
·Knowledge and/or experience in CMC dossiers, regulatory CMC and operations and compliance.
·Fluent in English (mandatory) and Chinese.
>>>Contact Information：
联系人：Frank Wang
联系方式：15680922101（微信同号）
邮箱：frank.wang@isaac-kenneth.com
