Regulatory Affairs Associate

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：

Regulatory Affairs Associate Manager

位置：

Europe/Middle East/Africa, United Kingdom, Reading, Berkshire

工作地点：

混合

你会做什么

Regulatory Affairs Associate

The Regulatory Affairs Associate oversees a range of regulatory activities for their assigned medicines, medical devices,

cosmetics and/or food supplement consumer products within their geographical and/or brand area of responsibility. Projects

may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority

questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications

where requested.

The Roles & Responsibilities include:

Regulatory Strategy

· Assists in the coordination, compilation & submission of new drug applications, cosmetics, medical devices, food

supplements or any similar product to the regulatory agencies within their geographical and/or brand area of

responsibility

· Collects and organizes information on regulatory requirements for quality, preclinical and clinical data to meet

applicable regulations.

· Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.

· Monitors the progress of the regulatory authority review process through appropriate communication with the

Health Authority.

· Prioritizes, plans and monitors allocated projects against defined timelines

· Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements

Regulatory Compliance

· Assists in the maintenance of compliance for all products with local regulations and quality system requirements

· Ensures that all assigned products comply with local regulatory and quality system requirements.

· Reviews and approves promotional materials for assigned local Kenvue products.

· Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.

· Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained

· Identifies & initiates local process improvement opportunities and manage changes as required

· Assists in the preparation for internal and external audits and inspections in collaboration with others

Specific requirements

· Relevant Bachelor's Degree or higher · 2+yrs related regulatory experience

Job Requirements

Essential knowledge and skills:

· Knowledge of consumer healthcare environment and product development

· Understanding of processes and departments within a healthcare company

· Effective time and organisation management

Core competencies

· Proficiency in English

· Excellent oral and written communicator

· Able to work under pressure and to tight time deadlines

· Able to work under own Initiative

· Analytical thinker

· Computer literate

· Able to work effectively in a multi-cultural, highly matrixed organization

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