Kenvueは現在、以下求人を募集しております。
Senior 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 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
The Senior Regulatory Affairs Specialist has an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements for regulatory submissions, approval pathways and compliance activities and the potential impact of these on business objectives.
Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan
Manages 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
Maintains compliance for all products with local regulations and quality system requirements
The Roles & Responsibilities include:
Regulatory Strategy
Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams
Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant.
Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non clinical data are consistent with the local regulatory requirements and support the proposed product classification and claims.
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.
Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level.
Regulatory Compliance
Maintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross functional experts as appropriate and implements locally
Ensures that all products comply with local regulatory and quality system requirements.
Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions
Reviews and approves promotional materials for assigned local Kenvue products and assists in claim support
Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
Ensures that the enterprise Regulatory systems are accurate and fully maintained
Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally
Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives
Supports internal and external audits and inspections in collaboration with quality function
Specific requirements
Relevant Bachelor's Degree or higher
6+yrs related regulatory experience
Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices
Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
Proficiency in English
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