合规标签助理总监
Regulatory Labeling Associate Director
**职位描述**
**岗位概述：**
监管标签高级专员将负责战略性的标签工作，并在特定治疗领域内，针对一个或多个产品执行全球标签级别（CCDS、USPI、EuSmPC）或多个ROW国家/地区的标签工作。该职位可能负责特定的业务流程，也可能在一定指导下负责TLP的开发和管理。
**主要职责和任务：**
- 确保符合标签治理要求及相关业务流程。
- 领导标签工作组，并在高级标签治理会议中代表标签工作。
- 为一个或多个产品开发并维护全球产品标签。这包括公司核心数据表和主要市场的标签，或多个其他地区市场特定的标签及相关的包装组件，可能还包括目标标签配置文件。
- 在质量、非临床和临床数据方面，具备熟练能力向相关方提供监管标签要求的建议，并对跨一个或多个产品在全球层面或特定治疗领域多个ROW市场的所有标签方面的监管机构互动进行监督，包括对问题的答复、谈判和检查。
**知识与技能：**
- 对全球标签要求有深入的专业知识，包括CCDS的开发和生命周期管理，以及全球监管机构的要求，包括FDA、EMA，可能还包含其他机构如加拿大卫生部、TGA。
- 具备高级能力，能够开发、使用和应用与监管全球和/或区域标签相关的框架，并利用这些信息支持与业务目标一致的监管职责。
- 展现出有效采用和利用新兴技术（包括AI驱动工具）的能力，并保持持续学习的心态，以加强监管策略、决策和运营效率。
- 主动跟进技术、AI、自动化、竞争情报以及监管环境的变化。
- 具备高级能力，能够系统且高效地规划、优先处理、领导和执行与监管全球和/或区域标签相关的个人工作、团队合作和项目。
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**Job Description**
**General/Position Summary**
The Regulatory Labeling Associate Director, Rest of World (ROW) is responsible for development and maintenance of product labelling for ROW markets across all therapeutic areas. This includes prescribing and patient information and associated business processes.
**Key Duties and Responsibilities**
- Provides individual contribution in development, submission, negotiation and approval of ROW labelling.
- Ensures compliance with labelling governance requirements and associated business processes.
- Leads Label Working Groups for ROW labelling topics and represents labelling at product-specific regional regulatory teams and senior labelling governance meetings.
- Works with Labeling Operations to ensure alignment with Package Component Labeling.
- Leads labelling strategy with an advanced ability to advise stakeholders of regulatory labelling requirements and oversight of health authority interactions regarding all aspects of labelling, including responses to questions, negotiations and inspections.
**Required Education Level**
- Bachelor’s Degree
**Required Experience**
- Extensive years of experience in regulatory affairs in the area of global labelling or related discipline or the equivalent combination of education and experience.
**Required Knowledge/ Skills**
- Expert level knowledge regarding labelling requirements globally, use of CCDS or reference label in the development and management of local labelling.
- Expert ability to develop, use, and apply knowledge of frameworks specific to regulatory responsibilities that align with business objectives.
- Expert ability to plan, prioritize, lead and execute individual work, teamwork, and projects related to regulatory labelling in a systematic and efficient manner. This includes the ability to balance cost, risk and benefits when developing timelines, aligning resources and delivering results.
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
**Flex Designation:**
Remote-Eligible
**Flex Eligibility Status:**
In this Remote-Eligible role, you can choose to be designated as:
1. **Remote**: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; **or select**
2. **Hybrid**: work remotely up to two days per week; **or select**
3. **On-Site**: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Remote
**Company Information**
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com