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 Summary:**
The Regulatory Labeling Associate Director will be responsible for strategic labeling and for executing on one or more products either at the global label-level (CCDS, USPI, EuSmPC) or in multiple ROW countries/regions for a given therapeutic area. This role may be accountable/responsible for specific business processes and may also be responsible for the development and management of a TLP with some guidance.
**Key Duties and Responsibilities:**
- Ensures compliance with labeling governance requirements and associated business processes.
- Leads label working groups and representing labeling at senior labeling governance meetings.
- Develops and maintains global product labeling for one or more products. This includes the company core datasheets and labeling for the major markets, or multiple rest of world market-specific labels and associated packaging components and may include target label profiles.
- Contributes to labeling strategy with a proficient ability to advise stakeholders of regulatory labeling requirements for quality, preclinical and clinical data and oversight of health authority interactions regarding all aspects of labeling across a one or more products at the global level or across several ROW markets for a given therapeutic area, including responses to questions, negotiations, and inspections.
**Knowledge and Skills:**
- Specialized depth of knowledge regarding labeling requirements globally, including development and life-cycle management of CCDS and of global regulatory authorities, including the FDA, EMA, and may include other authorities such as Health Canada, TGA.
- Advanced ability to develop, use, and apply knowledge of frameworks specific to regulatory global and/or regional labeling, and to use this information to support regulatory responsibilities that align with business objectives.
- Demonstrates the ability to effectively adopt and leverage emerging technologies, including AI-driven tools, and maintains a continuous learning mindset to strengthen regulatory strategy, decision-making, and operational efficiency.
- Proactively remains up to date on advances with technology, AI, automation, competitive intelligence and changes in the regulatory environment.
- Advanced ability to plan, prioritize, lead, and execute individual work, teamwork, and projects related to regulatory global and/or regional labeling in a systematic and efficient manner.
- Strong understanding of the compliance and operational requirements for labeling
**Education and Experience:**
- Bachelor’s degree, with a preference in a life sciences field
- Typically requires 8 years of experience in regulatory affairs in the area of global labeling or related discipline, or the equivalent combination of education and experience.
#LI-Remote
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.
**Pay Range:**
$161,600 - $242,400
**Disclosure Statement:**
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
**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