监管CMC经理 - 小分子（合同）
Regulatory CMC Manager - Small Molecule (Contract)
职位描述
化学制造控制经理将负责在国际地区内多产品项目的详细规划、准备和运营执行。
该职位参与监管CMC文件的准备和提交，并为各种跨职能团队提供监管支持。
主要职责和任务
- 执行生命周期管理（LCM）策略和已上市产品的提交，重点关注国际地区。
- 规划和执行国际监管CMC提交，包括制定内容计划并确保跨职能协调
- 审核监管提交中的CMC部分，以及与监管机构的互动和回应
- 与监管同事合作，制定全球监管CMC策略和提交
- 有效参与跨职能团队，可能作为指定产品和项目的主监管CMC联系人
- 支持监管评估和产品合规性主题的指导，包括变更控制、偏差和GMP调查
所需知识/技能
- 强大的人际沟通能力，能够与其他人员交流复杂信息并进行指导
- 熟悉监管指南（FDA、EMA、ICH、国际机构）
- 强大的问题解决能力，能够为管理层对整体评估达成一致
- 能够以开放、清晰、完整和及时的方式协作和沟通
- 具有强烈的规划和优先级意识，并有实际成果
所需教育水平和经验
- 本科学历，生物学、化学、药学、药品监管事务、生物制品或医疗器械等相关生命科学领域优先
- 通常需要5年制药行业或相关领域的经验
- 需要有支持小分子项目的经验
合同期限：12个月，有机会延长。
薪资范围
70美元/小时 - 80美元/小时
班次/工作时间
周一至周五；远程办公：EST时间
职位声明
此职位是临时职位，由第三方代理合作伙伴派驻至Vertex Pharmaceuticals（“Vertex”）。选定的人员将作为第三方代理合作伙伴的员工被录用；薪酬、医疗福利、其他福利及雇佣条款和条件将由第三方代理合作伙伴提供。
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Job Description
The Chemistry Manufacturing Controls Manager will be responsible for the detailed planning, preparation and operational execution of a multi-product program in the international region.
This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams.
Key Duties and Responsibilities
- Execute Lifecycle Management (LCM) strategy and submissions of marketed products with a focus in the international regions.
- Planning and execution of international regulatory CMC submissions, including creation of content plans and ensuring cross functional alignment
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
- Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
- Participates effectively in cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
- Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Required Knowledge/Skills
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, ICH, international agencies) guidelines
- Strong problem-solving skills and the ability to present the overall assessment for management alignment
- Ability to collaborate and communicate in an open, clear, complete and timely manner
- Strong sense of planning and prioritization, with demonstrated results
Required Education Level & Experience
- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- Typically requires 5 years of experience in the pharmaceutical industry or related field
- Experience supporting Small Molecule programs required
Contract length: 12 months with the chance to extend.
Pay Range
$70/hr. - $80/hr.
Shift/Hours
Monday–Friday; Remote: EST hours
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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Originally posted on Himalayas