Regulatory Affairs, Self Care Lead

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

We are seeking an experienced, strategic, and dynamic US and Global regulatory affairs lead to drive regulatory strategy and compliance for OTC drugs, medical devices, and OTC switch. This role is pivotal in shaping global regulatory pathways, ensuring compliance, and supporting business growth through proactive regulatory engagement.
 

Key Responsibilities

Regulatory Strategy

• Provides strategic input and technical guidance on global regulatory requirements for OTC drugs, medical devices, and OTC switch to enable product innovation and market access to product development teams.
• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.
• Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions
• Monitors implementation of regulatory strategies relative to product and clinical safety issues identified
• Provides regulatory guidance on strategy for proposed product claims/labeling and provided clinical and non-clinical data, to ensure compliance with the local regulatory requirements and to optimize the proposed product positioning.
• Prepares cross functional teams for interactions with regulatory authorities including FDA meetings
• Strong knowledge of FDA and monograph system, NDA pathway, 510(K) De Novo, EU MDR, and International Regulatory Frameworks.

Regulatory Compliance

• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches and advises internal stakeholders on a course of action.
• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products
• Negotiates with regulatory authorities on complex issues throughout the product lifecycle.
• Ensure that all applicable Processes, SOPs and working instructions are adhered to.
• Support internal and external audits and inspections in collaboration with quality function
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures (SOPs).
• Identify local process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives

Regulatory Advocacy

• Remains up-to-date on scientific and clinical advances that impact healthcare product development and assesses the relationship to regulation and regulatory issues.
• Drive new approaches to improve the development, review and oversight of regulatory frameworks for healthcare products.
• Engages with stakeholder groups to help shape science based regulatory decision making as required.

What we are looking for

Required Qualifications

• Relevant bachelor’s degree or higher 
• 10+yrs related regulatory experience 
• Expertise across a broad spectrum of Regulatory classifications including OTC drug Products, Cosmetics, RX-to-OTC Switch and/or Medical Devices
• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
• Excellent knowledge of required regulatory frameworks including OTC drug, medical devices, RX-to-OTC Switch regulation at a minimum
• Excellent personal and people leadership.
• Broad knowledge of consumer healthcare environment and product development.

Desired Qualifications

• 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.
• 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. 
• High degree of organizational and analytical skills, able to demonstrate sound judgment & develop creative solutions
• Ability to work autonomously as a high impact individual contributor driving projects with strong strategic problem solving skills.

Was haben Sie davon

Dies berücksichtigt eine Reihe von Faktoren, darunter den Arbeitsort, die Fähigkeiten des Kandidaten, die Erfahrung, das Bildungsniveau und die andere berufsbezogene Faktoren.

Kenvue ist stolz darauf, ein Arbeitgeber für Chancengleichheit zu sein. Alle qualifizierten Bewerber werden unabhängig von Rasse, Hautfarbe, Religion, Geschlecht, sexueller Orientierung, Geschlechtsidentität, Alter, nationaler Herkunft oder geschütztem Veteranenstatus für eine Beschäftigung in Betracht gezogen und nicht aufgrund von Behinderung diskriminiert.