Regulatory Affairs Manager Nordics
Q-Med AB / Biomedicinjobb / Uppsala
2023-02-23
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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 Description
Galderma is looking for a Regulatory Affairs Manager Nordics to work in our Uppsala site.
Reporting directly to the Head of Regulatory Affairs EMEAC, the Regulatory Affairs Manager Nordics is accountable for strategy development, planning and execution of Regulatory Affairs priorities for both new and in-line products across assigned product classes (medical devices and cosmetics, and medicinal products if applicable) in Nordics, in accordance with the regulations. Assist the QA Manager for Quality activities and tasks.
Key Tasks
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Manage the entire registration process including regulatory strategy development in partnership with global RA. Ensure timely approvals of new products and amendments to products in all the Nordics markets - Sweden, Denmark, Norway, Finland and Iceland
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Ensure compliance with, and maintenance of, existing product licenses
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Ensure regulatory advice and input is proactively provided to local business strategies with regards to feasibility, needs, and timelines, taking into account local regulations and local business needs
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Ensure review and approval of promotional and non-promotional materials ensuring their compliance with local regulations, code of conduct and internal guidelines. Develop and maintain effective working relationships with Health Authorities
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Contribute to shaping the regulatory environment in Nordics, driving an agenda to create an external environment in which our portfolio can thrive.
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Support the Quality Manager and manage activities related to Quality Assurance, such as establishing and maintaining the local Quality Management System and monitor its compliance status, to ensure that processes are established and effective
Skills & Qualifications
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Life Science degree, Pharmacist a plus
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At least 3-5 years work in Regulatory Affairs (pharma and medical device), Class III device regulatory knowledge a plus
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Regulatory Affairs experience in the Nordics
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Ability to act as a business partner who will guide the Nordics businesses in all Regulatory aspects to help enable sustainable business growth
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Knowledge of Quality Assurance and ability to assist the business' QA needs
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Agile mindset and learning agility. Able to work in a complex environment of diverse portfolio across product classes (medicinal products, medical devices, cosmetics).
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Professional level Swedish and English needed, other Nordic languages a plus
What we offer in return
You will be working with a global dermatology company with operations in 90 countries. The Uppsala site is also Galderma's global center for our aesthetics business and has operations in product development, manufacturing and marketing . We offer an opportunity to work in a dynamic and international environment where personal and professional development is encouraged. We are located along the river Fyrisån, 10 minutes by bike from Uppsala Central Station.
Next Steps
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If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
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The next step is a virtual conversation with the hiring manager
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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 2023-03-23
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "JR004761".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Q-Med AB (org.nr 556258-6882)
Arbetsplats Galderma
Kontakt Galderma
althea.diazsul@galderma.com Jobbnummer 7478547
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