Regulatory Affairs Manager to Galderma

About Galderma

Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically defined and medically proven innovative solutions for the skin. For more information, please visit www.galderma.com.

Job Description

The Regulatory Affairs Department at Galderma Uppsala is responsible for all Regulatory aspects of Galderma's aesthetic business at Global level. This includes new product registrations, line extensions and Life Cycle Management of the portfolio of products for both Pharmaceuticals and Medical Device.

We are now expanding our Medical Device Regulatory Team in Uppsala and looking for a Regulatory Affairs Manager to join this team. We manage a broad portfolio of products across almost 90 markets and are expanding our scope with several new innovation projects in our pipeline.

Job Responsibilities

The role will offer an opportunity to work with key development and line extension projects for our Medical Device portfolio of products. You will be responsible for dossier compilation, manage Life Cycle Management activities including variations, renewals, labelling changes etc and also represent Regulatory Affairs in the core project teams.

Your responsibilities:

* Regulatory representative in key development projects
* Marketing applications for new products at Global level

* License maintenance

* Development of regulatory strategies world-wide, including active communication with local Regulatory Authorities and Galderma affiliates.

* Coordinate submissions and related responses to questions to Regulatory Authorities

Surveillance of regulatory requirements - at Global level

Minimum Requirements

* You hold a university degree in a life science area such as Pharmaceutical Science or similar.
* You also have several years' experience of Regulatory Affairs within the Pharmaceutical or Medical Device industry, or from an Authority (Health authority, Notified Body or similar) perspective.
* You have experience of compiling and reviewing documents/reports according to Global regulatory guidelines.
* You are open-minded and willing to adapt to changes and enjoy working with others in a collaborative way, also across several cultures
* You are self-driven, flexible, methodical, with the ability to structure work and manage multiple requests while maintaining timelines
* You possess good communication skills and fluency in Swedish and English, both verbal and written. Strong writing, reading and reviewing skills are necessary.



Other Important Information

What we offer in return

As Galderma's Global Center of Excellence for Aesthetics we have in Uppsala a unique edge as we have on our site the whole product chain from research and development to production. Here our nearly 450 employees work on our world leading brands such as Restylane, Azzalure and Sculptra.

We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisån) in Uppsala only a 10 minute bike ride from Uppsala Central Station



Your application
We welcome your application (CV and letter) via our company website https://www.galderma.com/job-search
Apply as soon as possible though no later than 17th January. The selection process is ongoing.

Should you have questions about this opportunity you are welcome to contact

Sinéad Breen , Global Head of Regulatory Affairs at +46 768981230