Kenvueは現在、以下求人を募集しております。

Regulatory Affairs Associate

私たちがしていること

私たちKenvueは、日々のケアが持つ驚くべき力を信じています。100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID®など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。 

Who We Are

私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えたKenvuerであることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。 

Role reports to:

Regulatory Affairs Associate Manager

場所:

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

勤務地:

ハイブリッド

あなたがすること

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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