Regulatory Affairs, Self Care Lead

Regulatory Affairs, Self Care Lead

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

Vice President Regulatory Affairs NA

Posizione:

North America, United States, New Jersey, Summit

Luogo di lavoro:

Ibrido

Cosa farai

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.

Cosa c'è per te

$194,650.00 - $274,800.00

Questo tiene conto di una serie di fattori tra cui il luogo di lavoro, le competenze del candidato, l'esperienza, il livello di istruzione e altri fattori legati al lavoro.

Kenvue è orgogliosa di essere un datore di lavoro per le pari opportunità. Tutti i candidati qualificati saranno presi in considerazione per l'impiego in base al merito, indipendentemente da razza, colore, religione, sesso, orientamento sessuale, identità di genere, età, origine nazionale o stato di veterano protetto e non saranno discriminati sulla base della disabilità.