北京招聘

?Provides CMC regulatory support and guidance for assigned projects and interfaces with R&D/CMC, Project Management, Manufacturing, Quality, and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers.
?Manage interactions with CFDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information.
?Develop and implement effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and is able to interpret and apply local regulations and guidance’s to the life cycle of a drug product.
?Manage/prepare CMC document packages for regulatory submissions in support of development programs. This includes initial submission of INDs, CTAs and amendments to Health Authorities (HAs), and preparation of responses to questions from HAs balancing HA requirements and corporate objectives.
?Manage timelines in cooperation with Project Management on assigned projects.
?Review technical reports and CMC sections of IND, CTA, NDA, MAA, and other global submissions to support clinical trials and marketing applications, and their amendments in conformance with regulatory requirements, strategies and commitments.
?Work with regulatory CROs to identify regional/country-specific CMC requirements to support global applications.
?Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and provide strategic regulatory guidance for optimal implementation of changes.
?Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
?Other duties as assigned
职位要求：
REQUIREMENTS:
BS/BA Biochemistry, Chemistry, or Pharmaceutical Science; Advanced degree preferred.
Experience
Minimum 3 years of experience in a global CMC regulatory affairs position with expertise in small molecule projects and with product lifecycle from Phase 1 to post approval changes. Experience with small molecule injectable is a plus.

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。