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高级法规事务专员 - 动物健康

Senior Regulatory Affairs Specialist - Animal Health

职能支持限定地区(需当地身份)
公司AmerisourceBergen
薪资未公开
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间今天
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

我们的团队成员是所有工作的核心。在Cencora,我们共同肩负着创造更健康未来的责任,这里每个人都是我们实现这一目标不可或缺的一部分。如果你想在医疗健康的核心发挥作用,加入我们这个充满创新的公司,帮助我们改善世界各地人们和动物的生活。立即申请!

职位详情

高级法规事务专家 - 动物健康
加入一个不断壮大的法规咨询团队,支持美国市场创新的动物健康产品。
我们正在寻找一位经验丰富的高级法规事务专家 - 动物健康,为动物健康生物制品和药品提供实际的法规执行和运营支持。这是一个对法规专业人士来说令人兴奋的机会,可以参与整个产品生命周期的工作,并与跨职能团队合作,实现合规、及时且高质量的法规成果。
此职位最初将支持BI Vet动物健康客户,随着业务需求的变化,也有机会扩展到更广泛的动物健康和美国法规咨询项目中。
职位简介
高级法规事务专家负责支持美国法规事务活动,涵盖产品生命周期管理、法规提交、标签、产品管理、法规运营和合规性。这个职位适合一位具备强大执行能力、良好的法规判断力,并能在以客户为中心的环境中管理多项优先事项的人。
你将与法规事务、质量、制造、药物警戒、供应链和商业团队的内部和客户利益相关者密切合作,以确保法规目标高效且合规地实现。
你将负责:

  • 支持动物健康生物制品和药品的法规生命周期活动
  • 准备、协调并维护法规提交、产品注册及相关生命周期文件
  • 支持标签策略的执行、审查和实施活动
  • 保持法规文件、记录和提交跟踪的准确性
  • 支持产品管理和更广泛的法规运营活动
  • 协调年度报告、批准后变更和持续合规活动
  • 跨职能合作,支持法规里程碑的及时交付
  • 提供支持 for
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Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Senior Regulatory Affairs Specialist - Animal Health
Join a growing regulatory consulting team supporting innovative animal health products across the U.S. market.
We are seeking a seasoned Senior Regulatory Affairs Specialist - Animal Health to provide hands-on regulatory execution and operational support for animal health biological and pharmaceutical products. This is an exciting opportunity for a regulatory professional who enjoys working across the full product lifecycle and partnering with cross-functional teams to deliver compliant, timely, and high-quality regulatory outcomes.
This role will initially support the BI Vet Animal Health account, with the opportunity to expand into broader Animal Health and U.S. Regulatory consulting projects as business needs evolve.
About the Role
The Senior Regulatory Affairs Specialist is responsible for supporting U.S. regulatory affairs activities across product lifecycle management, regulatory submissions, labeling, product stewardship, regulatory operations, and compliance. This role is ideal for someone who brings strong execution skills, sound regulatory judgment, and the ability to manage multiple priorities in a client-focused environment.
You will work closely with internal and client stakeholders across Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, and Commercial teams to help ensure regulatory objectives are delivered efficiently and compliantly.
What You’ll Do:

  • Support regulatory lifecycle activities foranimal health biologics and pharmaceutical products
  • Prepare, coordinate, and maintainregulatory submissions,product registrations, and related lifecycle documentation
  • Supportlabeling strategy execution, review, and implementation activities
  • Maintain accurateregulatory documentation, records, and submission tracking
  • Supportproduct stewardshipand broaderregulatory operationsactivities
  • Coordinateannual reports,post-approval changes, and ongoing compliance activities
  • Partner cross-functionally to support the timely delivery of regulatory milestones
  • Provide support for additionalU.S. Regulatory consulting projectsas business needs grow and shift

What You’ll Do:

  • Support regulatory lifecycle activities foranimal health biologics and pharmaceutical products
  • Prepare, coordinate, and maintainregulatory submissions,product registrations, and related lifecycle documentation
  • Supportlabeling strategy execution, review, and implementation activities
  • Maintain accurateregulatory documentation, records, and submission tracking
  • Supportproduct stewardshipand broaderregulatory operationsactivities
  • Coordinateannual reports,post-approval changes, and ongoing compliance activities
  • Partner cross-functionally to support the timely delivery of regulatory milestones
  • Provide support for additionalU.S. Regulatory consulting projectsas business needs grow and shift

What We’re Looking For:

  • Bachelor’s degree in ascientific disciplineor related field
  • 5 to 10+ yearsof experience inregulatory affairsorregulatory operations
  • Experience supportingAnimal Health,biologics,vaccines,pharmaceuticals, or related regulated products
  • Familiarity withUSDA-CVBand/orFDA-CVMpreferred, but not required
  • Strong organizational skills with exceptional attention to detail
  • Excellent written and verbal communication skills
  • Proven ability to managemultiple projects, deadlines, and competing priorities
  • Ability to work independently while collaborating effectively with cross-functional teams

Why This Opportunity Stands Out:
This is more than a traditional regulatory role. It is an opportunity to join a dynamic consulting environment where your expertise will support meaningful animal health programs and where your scope can grow over time. If you are looking for a role that offers variety, visibility, and the chance to make an impact across multiple regulatory initiatives, this could be a strong next step in your career.
Ideal Candidate:
You are a proactive, solutions-oriented regulatory professional who enjoys balancing detail-oriented execution with cross-functional collaboration. You are comfortable navigating complex regulatory processes, maintaining high-quality documentation, and driving work forward in a fast-paced environment.
Apply Now
If you are passionate about advancing animal health products and bringing strong regulatory execution to a growing consulting team, we encourage you to apply.
What Cencora offers
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit
Full timeEqual Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Affiliated Companies
Affiliated Companies: Cencora Global Consulting Services US CorporationOriginally posted on Himalayas

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AmerisourceBergenUnited StatesFull Time今天
职能支持限定地区(需当地身份)

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