Regulatory Affairs, Self Care Lead

Regulatory Affairs, Self Care Lead

Что мы делаем

At Kenvue, мы осознаем необычайную силу повседневной заботы. Основанный на более чем вековом наследии и уходящий корнями в науку, мы являемся домом культовых брендов, включая NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® и BAND-AID®, которые вы уже знаете и любите. Наука – наша страсть; забота – это наш талант.

Кто мы

Наша глобальная команда – это ~ 22 000 блестящих людей с культурой рабочего места, где каждый голос имеет значение, а каждый вклад ценится. Мы увлечены идеями, инновации и стремление поставлять нашим клиентам лучшие продукты. Обладая опытом и эмпатией, быть Kenvuer означает иметь возможность влиять на миллионы людей каждый день. Мы ставим людей на первое место, заботимся о настолько, завоевываем доверие наукой и смело решаем – и вас ждут блестящие возможности! Присоединяйтесь к нам, чтобы формировать наше будущее и ваше. Для получения дополнительной информации, нажмите here.

Role reports to:

Vice President Regulatory Affairs NA

Location:

North America, United States, New Jersey, Summit

Место работы:

Гибрид

Что ты будешь делать

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.

Что в этом для тебя

$0.00 – $0.00

Это учитывает ряд факторов, включая место работы, навыки, опыт кандидата, уровень образования и другие факторы, связанные с работой.

Kenvue гордится тем, что является работодателем равных возможностей. Все квалифицированные кандидаты будут рассматриваться при приеме на работу на основе заслуг независимо от расы, цвета кожи, религии, пола, сексуальной ориентации, гендерной идентичности, возраста, национального происхождения или защищенного статуса ветерана, и не будут дискриминироваться по признаку инвалидности.