Regulatory Affairs CMC Manager

Regulatory Affairs CMC Manager

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:

DIRECTOR Global & EMEA Regulatory Affairs OTC

Ubicazione:

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

Luogo di lavoro:

Ibrido

Cosa farai

• 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 sei un individuo con disabilità, controlla il nostro "Pagina di assistenza per disabili per informazioni su come richiedere un alloggio.