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Regulatory Affairs Intern
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 Regulatory Affairs Specialist
場所:
Europe/Middle East/Africa, Spain, Community of Madrid, Madrid
勤務地:
フルオンサイト
あなたがすること
The Regulatory affairs Intern will participate to the coordination, compilation, submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies in Spain. In their role, they will cooperate with Commercial/Marketing teams.
Essential duties and responsibilities
Medicines Regulatory activities
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- New marketing authorization activities
- Maintenance activities of existing licenses: preparations of administrative,
quality regulatory packages and safety related variations for their submission to Healthcare Authorities (H.A.)
Artwork review and approval with the help of the Regulatory Specialist.Internal Aws tool user.
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- Review of promotional materials direct to Healthcare Professionals and consumers.
- New legislation monitoring, impact analysis and communication to business partners.
- H.A. tools: Fraccionamiento (Breaking‑up of SPCs and PILs).RAEFAR, LABOFAR
Specific requirements
Cosmetic Regulatory activities:
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- Artwork review and approval. Internal Aws tool user.
- Review of the promotional material for Healthcare Professionals, consumers and internal departments
- Scientific advice for promotional materials with the support of the Regulatory contact in the Regional Team
- Product information advice for Consumer affairs and consumer service
- Ensure completion of databases. xcskxlj
- New legislation monitoring, impact analysis and communication to business partners.
- New requests, notification of changes for the maintenance, renewals of National Codes of the CGCOF
Oral care Regulatory activities:
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- Renewal of licenses and variations for the maintenance of Hygiene products licenses (dental products)
Medical devices Regulatory activities:
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- Review of the promotional material for consumers and submission to the HA for approval: CPS
- Review of the promotional material for consumers: Healthcare Professionals
Job Requirements
Essential knowledge and skills:
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- Degree in Pharmacy or similar
- Master in Pharmaceutical Industry
- Fluent English
Core competencies
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- Communication & Knowledge sharing
- Functional Competencies
- Driving solutions
- Organization skills
- Strategic thinking
- Proactivity
What’s in it for you
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- Competitive Benefit Package
- Versátil work policy
- Learning & Development Opportunities
- Canteen
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。
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📌 Regulatory Affairs Intern (Madrid)
🏢 Kenvue
📍 Madrid