Regulatory Affairs Specialist

O que fazemos

At Kenvue, percebemos o extraordinário poder do cuidado diário. Construída com base em mais de um século de herança e enraizada na ciência, somos a casa de marcas icônicas - incluindo NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® que você já conhece e ama. A ciência é a nossa paixão; O cuidado é o nosso talento.

Quem somos

Nossa equipe global é de ~ 22.000 pessoas brilhantes com uma cultura no local de trabalho onde cada voz é importante e cada contribuição é apreciada. Somos apaixonados por insights, inovação e comprometidos em entregar os melhores produtos aos nossos clientes. Com experiência e empatia, ser um Kenvuer significa ter o poder de impactar milhões de pessoas todos os dias. Colocamos as pessoas em primeiro lugar, nos importamos ferozmente, ganhamos confiança com a ciência e resolvemos com coragem - e temos oportunidades brilhantes esperando por você! Junte-se a nós para moldar nosso futuro - e o seu. Para obter mais informações, clique em aqui.

Role reporta para:

Regulatory Affairs Associate Manager

Localização:

Europe/Middle East/Africa, United Kingdom, Reading, Berkshire

Local de trabalho:

Híbrido

O que você fará

Regulatory Affairs Specialist

Job purpose 

 The Regulatory Affairs Specialist is accountable for all regulatory activities associated with their assigned medicines, medical devices, cosmetics and/or food supplement consumer products within their geographical and/or brand area of responsibility. Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested. 

 

Essential duties and responsibilities 

 The Roles & Responsibilities include: 

Regulatory Strategy  

• Assists in 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 

• Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations. 

• 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, seeking opportunities to expedite regulatory approvals where possible.  

• Prioritizes, plans and monitors allocated projects against defined timelines 

• Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements  

Regulatory Compliance  

• Ensures that all assigned products comply with local regulatory and quality system requirements. 

• Reviews and approves promotional materials for assigned local Kenvue products. 

• Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator. 

• Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained  

• Identifies & initiates local process improvement opportunities and manage changes as required  

• Assists in the preparation for internal and external audits and inspections in collaboration with others 

 

Specific requirements 

• Relevant Bachelor's Degree or higher   

• 4+yrs related regulatory experience   

 

Job Requirements 

Essential knowledge and skills: 

• Knowledge of consumer healthcare environment and product development 

• Understanding of processes and departments within a healthcare company 

• Effective time and organisation management 

 

Core competencies  

• Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.  

• Good interpersonal skills; able to build effective personal networks internally and externally. 

• Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results. 

• Strong organizational and time management skills with an ability to work under pressure. 

• Able to work effectively in a multi-cultural, highly matrixed organization 

• Proficiency in English  

 

 

 

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