Job Description:

• Member of Executive Committee who participates in strategic decisions regarding thecompany's programs and pipelines.
• Proactively monitors global new drug discovery and development in the areas relatedto Pyrotech's core programs, and identifies partnership and out-licensingopportunities with global companies.
• Develops and maintains a network in the biopharmaceutical industry, especially withdecision makers of external collaboration of major organizations.
• Leads all business development activities and deal negotiations.
• Works with internal stakeholders to prepare required presentations and documents,and leads the preparation of due diligence.

Qualification:

• With al least 10 year experience of business development, in or out-license, orexternal collaboration in global pharma and/or in biotech.
• Drug discovery and development experience in oncology and immunology areapreferred.
• Highly skillful in communication, business development and deal making.
• PhD in Biology related field.

Job Description:

• 负责管理由内部研发活动产生的创新产品非临床开发工作，涵盖从先导候选化合物筛选至监管申报与审批通过的全流程
• 统筹协调毒理学研究、安全药理学评估、生物分析及DMPK（药物代谢与药代动力学）等非临床研究活动，确保项目在全生命周期内的高效推进
• 保障非临床研究交付成果与文件资料的及时性及合规性，满足临床试验申请、监管机构沟通及全球市场注册要求（包括研究者手册IB、研发期间安全性更新报告DSUR、年度报告AR、预审评会议资料pre-IND、临床试验申请IND/CTA及新药上市申请NDA等）
• 定期向内部相关项目团队汇报非临床研究进展，主导与CRO（合同研究组织）等外部合作伙伴的沟通协作，推动非临床研究执行

Qualification:

• 具有药理学、毒理学或相关学科硕士及以上学位
• 具硕士6年，博士至少3年在生物医药行业非临床药物开发方面的工作经验
• 对CDE、FDA和国际注册的要求以及非临床安全药理学和毒理学相关的指导方针(ICH、EMA)有较深入的理解
• 具备优秀的沟通和协作技能，确保与内部团队和外部合作者的有效互动与合作
• 英语读写流利

Job Description:

• 负责公司股改、融资、上市等资本运作法律事务，全程把控法律风险，保障资本项目合规高效推进；
• 负责公司日常全流程法律事务管理，涵盖合同管理、合规咨询、劳动人事、税务合规、制度体系建设等；
• 负责各类内外部法律文书起草与审核，为各部门提供全运营环节的法律咨询与风险防控支持；
• 为公司经营决策提供专业法律支撑，开展风险评估、预警并出具优化方案，保障重大决策合法合规；
• 参与搭建与完善公司合规管理体系，推动制度落地执行，组织法律合规宣导与培训，提升全员合规意识；
• 牵头处理各类诉讼、仲裁及法律纠纷，维护公司合法权益；负责商业秘密与信息安全法律保障工作；
• 完成上级交办的其他法律相关工作。

Qualification:

• 法律专业硕士及以上学历，已通过法律职业资格考试；
• 具备6–8 年法务工作经验，拥有生物医药企业全职法务背景，熟悉行业监管政策与业务合规要求；
• 深度熟悉股改、融资、上市全流程法律实务，有相关项目实操经验者优先；
• 逻辑严谨，风险研判与解决能力突出，能精准把握业务运营 + 资本运作双重法律与风控核心要点；
• 沟通协调能力强，具备优秀的跨部门协作与项目推进能力，责任心强。

Job Description:

• Execute/fulfills submission requirements and drives discussions to accelerate the health authority (HA) submission where possible.
• Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables.
• Partners with other functions to obtain information and/or data required for regulatory submissions and Represents Regulatory Affairs on cross-functional project teams
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.

Qualification:

• A minimum of a Bachelor’s degree with at least 3 years of working experience within a regulated environment
• Excellent written, verbal communication and presentation skills is required.
• A scientific and technical understanding of drug development regulations within scope of responsibility to provide strategic guidance and regulatory input for international submissions is required.
• The ability to demonstrate the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives is required.
• Knowledge of and experience with China/US FDA regulations/requirements and submissions is preferred.
• Previous experience working with cross functional teams within a matrix environment is preferred.