Regulatory Affairs CMC Manager

Regulatory Affairs CMC Manager

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:

DIRECTOR Global & EMEA Regulatory Affairs OTC

Localização:

Europe/Middle East/Africa, Sweden, Skane, Helsingborg

Local de trabalho:

Híbrido

O que você fará

• End-to-end responsibility for Module 3/CMC new product development and life cycle management
• Acts as regulatory CMC lead in new product development projects with responsibility for regulatory CMC strategy development and deployment
• Leads a team of regulatory affairs CMC product owners with responsibility for Module 3/CMC maintenance ensuring the success of life cycle management activities and roll-out of existing products
• Provides technical leadership and expertise to cross-functional R&D partners and life cycle management teams to support development of fit for purpose CTD Module 3/CMC documentation for marketing authorization applications and variations globally
• Develop strong partnerships with Regulatory Affairs partners, R&D, Marketing and Supply Chain
• Represents the Regulatory Affairs CMC function as appropriate in various regulatory and cross-functional teams and technical fora
• Creates an environment of operational excellence through regulatory expertise, management of CMC product owners and collaboration with cross-functional teams

​Knowledge and skills

• Relevant Bachelor's Degree or higher 
• 10+ years experience from regulatory affairs and/or pharmaceutical product development
• Expertise across regulatory classifications including medicinal products and medical devices as it relates to pharmaceutical CMC regulatory affairs
• Knowledge of regulatory frameworks globally as it concerns pharmaceutical product development and CMC requirements
• Experienced in developing and maintaining Module 2.3 and 3 and providing guidance to cross-functional partners in authoring CTD documents
• Strong project and people management skills
• Highly collaborative and strong sense of ownership
• Proficiency in English

Kenvue Helsingborg

The Kenvue site in Helsingborg, Sweden is the home of the strong and growing brand NICORETTE®, a global market leader in smoking cessation. In 2021 our production facility was recognized as a Lighthouse by World Economic Forum, marking us as a beacon in The Fourth Industrial Revolution.

The Helsingborg site is one of the largest employers in the city of Helsingborg, and the business is divided in two separate departments: Operations, where we house our manufacturing activities and R & D, our global development center for excellence working in three therapeutic areas for selfcare treatments: Smoking Cessation, Digestive Health and Cough & Cold. For more information, click here

Background checks in the recruitment process

As a final candidate in our recruitment process, you may be subject to a background check. This process is important for us to ensure the quality of our recruitment process.

As part of this, it is important that we encourage you to make sure that the information in your CV is correct before submitting your application to us.

To carry out these background checks, we use a background check company. Different checks may be carried depending on the position that you are applying for. This could be, for example:

• Reference checks
• CV-validation
• Financial checks
• Litigation checks, including criminal cases

The background check company is an independent data controller for any personal data that they will process during the check, and if you have any questions about the processing, you may turn to the background check company.

Due to our business activities and daily operations, we may also carry out drug tests as part of our recruitment process.

Se você for um indivíduo com deficiência, consulte nossa página Página de assistência a deficientes para obter informações sobre como solicitar uma acomodação.