Regulatory Affairs & Compliance Manager Nordics
Q-Med AB / Biomedicinjobb / Uppsala
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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.
Galderma Nordics is looking for a Regulatory Affairs & Compliance Manager Nordics. The role is split 50% working Regulatory Affairs and 50% Compliance.
For Regulatory Affairs, you will guide regulatory strategy to provide direction for planning and coordinating activities related to product regulatory (biologicals, chemical drugs and medical devices), drugs CMC regulatory, regulatory operations and scientific & medical writing on both new and in-line products, in accordance with health authorities.
For Compliance you will be accountable for compliance strategy, its programs and policies related to the standards established by the business to comply with applicable external legislation/regulations.
Key Tasks
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Oversee the effectiveness of the compliance program and foster a culture of integrity and ethical business practices.
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Ensure compliance with global standards as well as local laws and regulations, guiding implementation of standards and compliance initiatives.
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Support review, approval and documentation for local HCP/HCO compliance and cross-border activities following relevant policies and procedures, including management of disclosure obligations.
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Direct regulatory strategy development and execution, ensuring regulatory advice and input is proactively provided to local business strategies.
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Coordinate and manage registration priorities, strategies, and preparation of dossiers for new and old products. Support global new product & life cycle management-projects, working with other stakeholders
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Ensure high quality and timely submissions, coordinating with distributors or third parties where applicable.
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Prepare and submit regulatory affairs applications such as new product registrations to meet country's business objectives and timelines.
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Perform regulatory maintenance of registered products or ingredients to ensure products remain compliant with all relevant government, industry, and corporate requirements throughout their marketed life.
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Review proposed product labels for regulatory assessment and submit to register label changes to the relevant health authority
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Co-ordinate artwork amendments and tracking of packaging modifications
Skills & Qualifications
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Pharmacist Degree / Bachelor's degree in pharmaceutical science.
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Experience in Regulatory Affairs & (HCP) Compliance in the field of medicinal products & medical devices. Cosmetics a plus
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In-depth knowledge of the pharmaceutical industry across the Nordics country cluster (Sweden, Denmark, Finland, Norway, Iceland).
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Ability to manage senior stake holders
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Has worked with cross functional matrix project teams
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Mandatory IMA training (for information & marketing managers) by LIF (Trade Association of the Pharma industry in Sweden).
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 2023-07-06
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "JR005681".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Q-Med AB (org.nr 556258-6882)
Arbetsplats Galderma
Kontakt Galderma
althea.diazsul@galderma.com Jobbnummer 7818321
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