Regulatory Affairs Manager

GALDERMA INTRO BLURB

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.

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

Job Description:

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 18 March 2023. The selection process is ongoing and the role may be filled prior the last application date.