Regulatory Affairs Manager
Q-Med AB / Biomedicinjobb / Uppsala
2022-09-09
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hela Sverige Galderma is the world's largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we're in shapes our life stories, we are advancing dermatology for every skin story. For more information, please visit our website:
https://www.galderma.com/careers Regulatory Affairs Manager to Galderma
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 Regulatory Affairs Manager to take on a roll within the team.
About the role
As Regulatory Affairs Manager you will represent Regulatory Affairs in 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:
* Provide regulatory expert advice in project and line related activities
* Compile overall regulatory strategy within projects for new products and line extensions
* Regulatory strategy in connection to labeling and other changes
* File and obtain marketing applications worldwide
* License maintenance activities
* Filing of clinical trial applications to authorities
* Coordinate compilation of new and updated labeling material
* Compile, review and approve documentation for regulatory purposes
* Remain updated on current regulatory requirements
* Contacts with regulatory bodies, affiliates, partners, consultants and distributors
* Tracking of regulatory status and plans within respective product responsibility
* Participate in authority meetings
* Review and approve Sales Promotion material
About you
* You hold a university degree in a life science area such as Pharmaceutical Science or similar.
* Experience of Regulatory Affairs within the Pharmaceutical or Medical Device industry, or from an Authority (Health authority, Notified Body or similar) perspective is a merit.
* 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.
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 CAREERS | Galderma
Apply as soon as possible though no later than the 2nd of October 2022. The selection process is ongoing and the role may be filled prior the last application date.
About the company
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.Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2022-09-09ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2022-09-30
Klicka på denna länk för att göra din ansökanFöretagQ-Med AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "JR003100".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Q-Med AB (org.nr 556258-6882)
Arbetsplats Galderma
Kontakt Galderma
mathilda.ostensson@galderma.com Jobbnummer 6963494
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