Kenvueは現在、以下求人を募集しております。
Regulatory Affairs Specialist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 Specialist
Job purpose
The Regulatory Affairs Specialist is accountable for all regulatory activities associated with 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.
Essential duties and responsibilities
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 evaluates 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, seeking opportunities to expedite regulatory approvals where possible.
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
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
4+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
Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
Good interpersonal skills; able to build effective personal networks internally and externally.
Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
Strong organizational and time management skills with an ability to work under pressure.
Able to work effectively in a multi-cultural, highly matrixed organization
Proficiency in English
障害のある個人の方は、宿泊施設のリクエスト方法について障害支援ページを確認してください。
