Regulatory Affairs Manager

Galderma Uppsala is expanding the Medical Device Regulatory Affairs team and we are looking for a Regulatory Affairs Manager to join us.



As Regulatory Affairs Manager you will represent Regulatory Affairs in development and life cycle management projects, including new product registrations and geographical expansions. You will be responsible for co-ordination and dossier compilation. The role also includes managing life cycle management activities including variations, renewals and labelling changes.



Key Tasks:

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Provide expert advice on regulatory affairs for project and line related activities
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Develop regulatory strategy for new products and line extensions
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File and obtain marketing applications worldwide
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File clinical trial applications to authorities
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Coordinate compilation of new and updated labeling material
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Compile, review and approve documentation for regulatory purposes
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Contacts with regulatory bodies, affiliates, partners, consultants and distributors



Skills & Qualifications

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At least a BSc in Life Sciences or Engineering.
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Regulatory affairs experience with medical devices and/or pharmaceuticals
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Professional level Swedish and English is needed.



What Galderma offers:



You will be working with a global dermatology company with operations in 90 countries. The Uppsala site is Galderma's global center for our aesthetics business and has operations in product development, manufacturing and marketing. We offer an opportunity to work in a dynamic and international environment where personal and professional development is encouraged. We are located along the river Fyrisån, 10 minutes by bike from Uppsala Central Station.



Your application

We welcome your application (CV and letter) via our company website CAREERS | Galderma



Apply as soon as possible though no later than the 22nd of December 2022. The selection process is ongoing and the role may be filled prior the last application date.