Senior Regulatory Affairs Specialist

Was wir tun

Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.

Wer wir sind

Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.

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Was Sie tun werden

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  

Wenn Sie eine Person mit einer Behinderung sind, besuchen Sie bitte unsere Behindertenhilfe für Informationen darüber, wie Sie eine Unterkunft anfordern können.