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 looking for a Regulatory Affairs Manager to join the Medical Device RA team in Uppsala for a fixed term contract of 18 months.
About the role
The role will offer an opportunity to work with development and line extension projects for the Medical Device portfolio of products. You will be responsible for dossier compilation, submissions, manage variations and represent Regulatory Affairs in different teams.
- Marketing applications for new products at Global level
- License maintenance
- Coordinate submissions and related responses to questions to Regulatory Authorities
- Surveillance of regulatory requirements at Global level
- You hold a university degree in a life science area such as Pharmaceutical Science or similar.
- Experience of compiling and reviewing documents/reports according to regulatory guidelines and/or experience of a similar role in a Pharmaceutical or Medical Device environment, would be considered a merit.
- You are open-minded and willing to adapt to changes and enjoy working with others, across cultures, in cross-functional and collaborative ways
- 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.
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 and marketing. 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.
We welcome your application via our career page on www.galderma.com/job-search.
Apply as soon as possible, though no later than 19 January 2020. The selection process is ongoing, and the position may therefore be appointed before the end of the application period.
Should you have questions about this opportunity you are welcome to contact Kristine Nygren, Manager of the Medical Device team +46 768981087
About the company
Galderma is a global leader in medical solutions for the skin, hair and nails. The company has been developing its extensive range of medically-proven solutions since its creation in 1981. It exclusively partners with healthcare professionals to target a variety of dermatological conditions and skin needs.
Headquartered in Lausanne, Switzerland, Galderma has more than 5,500 employees and 35 affiliates around the world. Its products are distributed in over 100 countries. Its development centers and manufacturing facilities are dedicated to providing a wide range of innovative and science-based medical solutions to meet the highest standards of safety and efficacy.
Galderma manufactures many well-respected brands, including Epiduo™ Restylane® Oracea® Differin® Mirvaso® Soolantra® Loceryl® Benzac® Excipial® Metvix® Azzalure® Tri-Luma™ Cetaphil® and Daylong™