深圳招聘

职位描述：
Essential Functions and Responsibilities:
These may include but are not limited to:
- Lead and manage the submission of regulatory applications and documents, including responses to information requests, included in the company’s internal or partnered submissions
- Represent Regulatory Affairs at team meeting and apply influence and negotiation skills to resolve issues
- Lead and manage cross-functional meetings to drive project development results
- Create and maintain regulatory timelines and track deliverables to timelines to ensure that internal and partner regulatory submission timeless are met
- Develop regulatory strategy and provide strategic input and regulatory advice to project teams
- Support the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages
- Provide critical review of documents (SOPs, protocols, and reports) related to clinical, drug safety, nonclinical or manufacturing, as necessary
- Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks
- Assure compliance with U.S. and China regulations
- Maintain knowledge of current global regulations, and guidance governing drugs and biologics in all phases of development
- Work cross functionally with Clinical, safety, research, quality, manufacturing, product management, etc.
   
Qualifications
- A minimum of a MS in life sciences with at least 5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries (an equivalent combination of education and experience may be considered)
- Demonstrated experience with U.S. submissions and a working knowledge of FDA/EMA regulations, the regulators, and the approval process. Experience with European/global submissions is a plus.
- Experience with oncology indications is preferred
- Experience in applying regulatory knowledge to various situations and serve as a source of competitive advantage to the company
- Experienced in all components of regulatory submissions including chemistry, manufacturing and control, non-clinical, and clinical documentation is further required
- A record of successful U.S. submissions for biologics and drugs which include INDs, NDAs/BLAs, MAAs, Annual Reports, and Amendments
- Excellent operational skills including planning, organizing and the ability to deal effectively with a variety of personnel both internally and outside the company
- Sound scientific judgment, Excellent problem solving skills and quality-driven.
- Demonstrated management, leadership and teamwork skills.
- Excellent writing, communication, and interpretive skills
- High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently
- Excellent verbal and written communication skills; proficient oral and written skills in both English and Mandarin.
- Enthusiasm and passion to for conducting creative scientific research.
- Additional experience in a smaller biotech company is a plus. RAC certification is preferred
- Software knowledge: Windows, MS Office (Outlook, Word, Excel)

    塔吉瑞生物成立于2014年8月，致力于研发具有自主知识产权的最新一代临床亟需小分子靶向抗肿瘤创新药，成立至今已申报100余项国际一类新药专利。
    公司研发实力得到知名投资机构和业界高度认可。目前自主开发的最新一代靶向抗慢粒白血病、肺癌等创新药即将进入临床试验。公司欢迎有识之士加入我们，一起努力更快为癌症病人带来创新疗法。