Kenvue 目前正在招聘 a：
我们做什么
在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。
我们是谁
我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.
Role reports to：
COORD ASSUN REGUL位置：
Latin America, Brazil, Sao Paulo, Sao Jose dos Campos工作地点：
混合你会做什么
The Sr Analyst, Regulatory Affairs is responsible to manage/develop the successful coordination, compilation, submission and approval of New Drug Applications, Abbreviated New Drug Applications and Investigational New Drug applications to Latam Health Authorities, as well is responsible for ensuring compliance with regulatory agency regulations and interpretations, preparing responses to regulatory agencies' questions and other correspondence.
Key Responsibilities
- Serve as the LATAM CMC Operations Subject Matter Expert (SME), leading the authoring, review and compilation of CTD Module 3 dossiers for regulatory submissions across LATAM markets, providing technical guidance on CMC regulatory requirements and lifecycle management activities, while mentoring colleagues and driving knowledge sharing and best practices across the organization
- This position will work closely with management and cross-functional partners to develop regulatory strategies and various submission packages throughout the development process and through filing and post approval.
- Execute CMC regulatory strategies with internal research and development, and other technical/scientific colleagues
- Collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings
- Implement regulatory strategies for new and existing products in compliance with local and international regulations.
- Provide regulatory guidance and support to cross-functional teams.
- Prepare and submit regulatory submissions to health authorities.
- Monitor and communicate changes in regulatory requirements to ensure compliance.
- Collaborate with internal and external stakeholders to ensure regulatory compliance throughout the product life cycle.
- Contribute to the development and maintenance of regulatory policies and procedures.
- Provide regulatory training and support to colleagues as needed.
- Lead and manage regulatory activities for new drug applications, abbreviated new drug applications, and investigational new drug applications
- Develop and maintain reporting schedules for new drug application and investigational new drug applications
- Identify and implement best practices for Regulatory Affairs processes to improve efficiency and effectiveness
- Provide solutions to a variety of problems of moderate scope and complexity
- Ensure quality and compliance in all actions
What we are looking for
Required Qualifications
- Bachelor's Degree in Pharmacy, Chemistry, Chemical Engineering or related scientific field.
- Solid experience authoring and compiling all parts of Module 3 CMC sections is required
- Solid experience of pharmaceutical industry experience is required
- Demonstrated experience supporting submissions and regulatory interactions with LATAM Health Authorities, including ANVISA, COFEPRIS and other regional agencies.
- Strong knowledge of pharmaceutical manufacturing processes, analytical methods, specifications and lifecycle management activities.
- Strong knowledge of local and international regulations
- Experience with regulatory submissions and agency interactions
- Ability to work independently and as part of a team
- Strong attention to detail and organizational skills
- Ability to manage multiple projects and priorities
- Intermediate to advanced English proficiency (written and verbal).
- Proven ability to mentor and train colleagues on regulatory CMC topics.
Desired Qualifications
- Intermediate to advanced Spanish proficiency.
- Experience supporting global products and global submission programs.
- Experience working in a regional LATAM role.
- Experience with small molecules and NCE products.
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