Global R&D - Senior Regulatory Affairs Manager

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.



Om Galderma

Galderma, världens största oberoende globala dermatologiska företag, grundades 1981 och finns i 100 länder med en omfattande produktportfölj för behandling av olika hudåkommor. Företaget samarbetar med vårdpersonal världen över för att tillgodose människors dermatologiska behov under livets olika faser. Galderma är ledande inom forskning och utveckling av vetenskapligt definierade och medicinskt dokumenterade lösningar för huden och dess åkommor. Mer information finns på www.galderma.com/se

Job description / Arbetsbeskrivning

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 manage a broad portfolio of products across almost 90 markets and are expanding our scope with several new innovation projects in our pipeline

We are now expanding our Medical Device Regulatory Team in Uppsala and looking for a Senior Regulatory Affairs Manager to take on a roll within the team.

Job responsibilities / Ditt uppdrag

About the role
As Senior Regulatory Affairs Manager you will represent Regulatory Affairs as Regulatory Lead in key development and life cycle management projects. You will be responsible for co-ordination and dossier compilation. The role also includes managing Life Cycle Management activities including variations, renewals, labelling changes etc .

Your responsibilities would include:

* Act as Global Regulatory lead within multi-functional project teams, provide support and influence decision-making in order to enable project delivery within defined targets.

* Analyze regulatory requirements and develop regulatory strategies world-wide, including active communication with local Regulatory Authorities and Galderma affiliates.

* Deliver high quality regulatory documentation for all activities either Development projects or Life Cycle Management Projects.

* Represent Regulatory Affairs in internal and external audits.
* Geographical Expansion of the portfolio

* License maintenance
* Surveillance of regulatory requirements - at Global level

Minimum requirements/ Är du den vi söker?

About you

* 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/ Frågor och ansökan

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 550 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 collaborate for this recruitment with PeakSearch. Please apply for the position at www.peaksearch.se.
If you have questions please contact Jarl Molin jarl.molin@peaksearch.se 070-560 20 56

Apply as soon as possible though no later than August 16. The selection process is ongoing. Welcome!