Regulatory Affairs Manager
Q-Med AB / Biomedicinjobb / Uppsala
2024-05-13
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hela Sverige At Galderma we're unique and we embrace difference.
Whether it's the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising and rewarding people for the contribution they make - working here isn't like anywhere else.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Job Title: Regulatory Affairs Manager
Location: Uppsala, Sweden (hybrid)
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 for Medical Devices. You will be responsible for the regulatory strategy, co-ordination and compilation of the dossier. 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
Skills & Qualifications
* 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
You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
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 600 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.
Next steps
We welcome your application via our company website CAREERS | Galderma. If you are currently an employee of Galderma, we welcome your application via our internal career site via Workday. Apply as soon as possible though no later than the 9th of June. The selection process is ongoing and the role may be filled prior the last application date.
* If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
* The next step is a virtual conversation with the hiring manager
* The final step is a panel conversation with the extended team
Our people make a difference
At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2024-06-03
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "JR009776".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Q-Med AB (org.nr 556258-6882)
Arbetsplats Galderma
Kontakt Galderma
mathilda.ostensson@galderma.com Jobbnummer 8675529