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:
Senior Manager, Regulatory Affairs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 is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Skin Health & Beauty / Essential Health franchise.
Evaluates and coordinates the regulatory deliverables for cosmetic &/or medical devices, within their geographical and/or brand area of responsibility
Develops effective partnerships with R&D, Franchise (Marketing) and local regulatory colleagues.
Assists in the preparation of technical documentation for the registration and maintenance of products throughout their whole lifecycle
Represents the Regulatory Affairs function as appropriate within the Skin Health & Beauty / Essential Health Franchise.
The Roles & Responsibilities include:
Regulatory Strategy
Works with local and regional regulatory colleagues to develop global and/or regional regulatory
Organizes materials from preclinical and clinical studies for review and assists in the review process.
Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines, as required.
Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings.
Tracks the status of applications under regulatory review and provides updates to the regulatory team
Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at regional level.
Regulatory Compliance
Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
Participate in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs and working instructions
Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally
Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives
Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
Regulatory Advocacy
· Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.) and maintains information resources.
· Supports in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant).
Specific requirements
Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
Works with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit.
Other features of the job
Represents Regulatory Affairs on cross-functional product/project teams and provides regulatory advice.
Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts.
Back up activities
Represent the Senior Manager Skin Health & Beauty / Essential Health as delegate on request
Job Requirements
Essential knowledge and skills:
Relevant Bachelor's Degree or higher
Expertise across a broad spectrum of Regulatory classifications including Cosmetics & Commodities
Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory
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Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
Proficiency in English
Core competencies
Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
Strong interpersonal skills; able to build effective personal networks internally and externally.
Highly 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.
Demonstrable commercial focus and business acumen which will enable him/her to thrive in a fast-paced dynamic and results-driven environment.
In-depth knowledge of the business, organizational goals, Regulatory Affairs function, and cross functional business partners to make informed business decisions and create and execute business strategies. Ability to represent RA function on cross-functional teams and governance forums.
Able to work effectively in a multi-cultural, highly matrixed organization
Experience in cultivating and leveraging strategic networks and partnership
What’s in it for you?
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
Extensive Learning & Development Opportunities
Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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