Regulatory Affairs Manager to Galderma

Nestle / Apotekarjobb / Uppsala
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We are now looking for our next star to join our Medical Device Team in Uppsala. Do you want to work in a global organization that is currently in an exciting and expansive phase? Then this can be the role for you!

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. This is a permanent position based in Uppsala, reporting to the Manager of Regulatory Affairs Medical Device Regulatory Affairs.

About the role
The role will offer an opportunity to work with key development and line extension projects for the Medical Device portfolio of products. You will represent Regulatory Affairs in the Development core project teams and the work will consist of coordinating activities as well as more hands on tasks such as compilation of regulatory documents and dossiers. This global role entails collaboration with internal experts of different disciplines within the company and there will also be frequent communication and coordination of activities at affiliate level world-wide.

Your responsibilities:
* Regulatory representation in key development projects and cross-functional teams
* Marketing applications for new products world-wide
* License maintenance, including coordination of submissions at affiliate level
* Regulatory strategies world-wide
* Coordinate submissions and related responses to questions from Regulatory Authorities
* Surveillance of regulatory requirements - at Global level
* Review and internal approval of Marketing and Promotional materials



About you
* You should have several years' experience of Regulatory Affairs, within the Pharmaceutical or Medical Device industry.
* We see experience from Clinical or Medical Affairs to be of merit for this role.
* You hold a university degree in a life science area such as Pharmaceutical Science or similar
* You should have experience of compiling and reviewing regulatory and scientific documents according to regulatory guidelines within the Pharmaceutical industry
* You are open-minded and willing to adapt to changes and enjoy working with others in a collaborative way, also across 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.

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.

Your application
We welcome your application (CV and letter) via our company website https://www.nestleskinhealth.com/job-search. Apply as soon as possible though no later than 5 April 2019. The selection process is ongoing.



Should you have questions about this opportunity you are welcome to contact recruiting manager Sinéad Breen, Global Head of Regulatory Affairs at +46 768981230.



About the company
Galderma is a global leader in medical solutions for the skin, hair and nails, wholly-owned by Nestlé Skin Health, a subsidiary of Nestlé. 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.

Varaktighet, arbetstid
FULLTIME PERMANENT

Publiceringsdatum
2019-04-03

Ersättning
Fixed salary

Så ansöker du
Sista dag att ansöka är 2019-04-07
Ange följande referens när du ansöker: 190001FF
Klicka på denna länk för att göra din ansökan

Kontakt
Not Specified

Företag
Nestle

Adress
Nestle
Not Specified
75228 Uppsala

Kontorsadress
Not Specified

Jobbnummer
4708312

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