成都招聘

ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Define and execute the global CMC/quality regulatory strategy for Retrophin products including maintaining and extending product registrations in United States, European Union, Asia
- Assure accurate and timely compilation and submission of regulatory documentation
- Lead the Hinova Global CMC/Quality Regulatory function by providing direction, guidance, and mentorship to direct reports, and CMC colleagues
- Direct and lead cross-functional submission teams to ensure creation and submission of global CMC/quality regulatory documents (NDA, MAA, Briefing documents, Variations, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives
- Manage CMC regulatory strategies and plans to ensure alignment with the overall project plan and business strategy
- Contribute to quality related functions such as GMP requirements, draft and review SOP's, review quality and supplier agreements
- Remain knowledgeable about current regulations and guidance, interpret and notify appropriate personnel of any changes, updates or revisions
- As the global CMC/quality regulatory expert, ensure any necessary knowledge is transferred throughout the Regulatory team and internal stakeholders
- Support new Business Development initiatives including due diligence and regulatory technical assessments as needed.

Qualifications
- M.S. degree or Ph.D. Degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
- 15+ years of experience in the pharmaceutical/biotech industry
- 8+ years of experience in pharmaceutical development of small molecules drug candidates
- 5+ years of experience in a regulatory leadership role
- Authored CMC sections of regulatory filings for US, Europe, and Japan
- Strong knowledge of current US and EU regulations and cGMPs, knowledge of Chinese regulations and cGMPs is a plus
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
- Strong cross-functional team experience
- Demonstrates strong problem solving and leadership skill sets
- Fluent in both English and Chinese (mandarin)
- Travel, as needed
- May need to stay at Chengdu, the headquarter of Hinova for a period of time as needed

海创药业有限公司是国家高新技术企业，总部坐落于中国成都，在美国、澳大利亚等地设有分支机构，面向全球市场开展新药研究及产业化。公司依托全球领先的氘代、PROTAC、高端制剂等技术平台，开发具有广阔市场潜力的重大新药品种，目前有包括治疗前列腺肿瘤、乳腺肿瘤、痛风等疾病的多个创新药物处于临床和临床前不同研究阶段。已建立了包括药物化学、生物筛选、工艺研究、质量研究、注册申报、临床研究、生产外包等完整药物研发和产业化体系。

海创现有产品管线中，HC-1119（治疗去势抵抗性前列腺癌新药）已经启动全球多中心临床III期试验；HP501（治疗痛风和高尿酸血症新药）已获得NMPA颁发的《临床试验通知书》，正在四川大学华西医院GCP中心开展临床I期试验。公司已申请 PCT和中国发明专利超过100项，获得中国、美国、日本、欧洲等国家和地区专利授权30项。

海创药业组建了由来自全球知名世界500强企业的十余位海归专家组成的核心管理团队，并引进了包括诺贝尔奖获得者、美国两院院士、中国科学院院士以及临床医生等组成的科学顾问委员会。公司荣膺国务院重点华侨华人创业团队、四川省顶尖创业团队、成都市顶尖创业团队等荣誉。