高级总监，全球法规标签与广告促销
Associate Director, Global Regulatory Labeling and Ad Promo
在Kailera，我们勇敢、真实，并致力于开发能赋予人们改变生活、提升整体健康水平的疗法。我们以创业精神和团队合作文化为根基，共同努力推进Kailera在肥胖及其相关疾病领域创新疗法的发展。
我们热衷于打造一个包容性的工作环境，促进协作、诚信和卓越。随着公司的发展，我们寻求拥有不同背景、文化、观点和经验的最优秀人才加入我们的团队。
你将负责：
全球监管标签与广告宣传主管将最初负责产品标签和非推广策略，以支持组织目标并保持监管合规。该职位将与跨职能团队合作，与关键的内部和外部成员配合。
职责：
- 领导美国处方信息、患者标签、用药指南、使用说明（IFU）、主要和次要（纸箱）标签以及推广标签的开发、审查和维护
- 提供监管指导，确保产品标签在整个研发、注册、上市及上市后生命周期管理过程中符合法规要求
- 与临床、CMC、医学、安全、设备工程、技术运营和商业团队合作，确保标签内容准确反映现有数据和监管要求
- 支持与FDA的标签谈判，并管理已批准标签更新的实施
- 评估拟议的安全性、有效性及科学声明，确保其与已批准标签一致
- 作为医学、法律、监管（MLR）评审流程的核心成员。与MLR流程负责人合作
- 确保符合FDA法规，包括：
- 食品药品化妆品法（FD&C Act）要求
- FDA广告和推广法规
- OPDP指南和执法趋势
- PhRMA代码要求
- 公司政策和程序
- 提供监管建议，支持合规且有效的非推广和推广沟通
- 监控与标签和推广审核相关的FDA指南变化、执法行动、警告信和行业最佳实践
- 参与标准操作规程（SOP）、政策和治理流程的制定和维护
所需资格：
- 硕士学位，药学、医学或相关领域
查看英文原文
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What You’ll Do:
The Associate Director, Global Regulatory Labeling and Ad Promo will be initially responsible for product labeling and non-promotional strategies to support organizational goals while maintaining regulatory compliance. This Associate Director will work on cross-functional teams, partnering with key internal/external team members.
Responsibilities:
- Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use (IFU), primary and secondary (carton) labeling, and promotional labeling
- Provide regulatory guidance to ensure compliance with regulations on product labeling throughout development, registration, launch, and post-approval lifecycle management
- Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams to ensure labeling content accurately reflects available data and regulatory requirements
- Support labeling negotiations with FDA and manage implementation of approved labeling updates
- Evaluate proposed safety, efficacy, and scientific claims for consistency with approved labeling
- Serve as a core member of the Medical, Legal, Regulatory (MLR) review process. Collaborate with MLR process owner
- Ensure compliance with FDA regulations, including:
- FD&C Act requirements
- FDA advertising and promotion regulations
- OPDP guidance and enforcement trends
- PhRMA Code requirements
- Company policies and procedures
- Provide regulatory recommendations to support compliant and effective non promotional and promotional communications
- Monitor evolving FDA guidance, enforcement actions, warning letters, and industry best practices related to labeling and promotional review
- Contribute to the development and maintenance of SOPs, policies, and governance processes
Required Qualifications:
- Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience including product labeling or a bachelor’s degree with 10+ years
- Established working knowledge of regulatory guidelines and regulations (US and international); with a particular focus on product labeling and advertising promotion
- Demonstrated deep knowledge of the integrated drug development process
- Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
- Demonstrated ability to assess and manage risk in a highly regulated environment
- Strong written, spoken and presentation communication
- Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities
- Travel expected (10-15%)
Education:
· Bachelor’s degree with 10+ years of experience or Advanced degree (such as PhD, PharmD, MS, MBA) with 5+ years of experience
Salary Range
$155,000—$190,000 USD
For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
E-Verify:
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
Originally posted on Himalayas