我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

Role reports to：

位置：

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你會做什麼

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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