Regulatory Project Manager for Pharmaceuticals
4 days ago
We are seeking a Regulatory Project Manager for Pharmaceuticals to join our consulting team at Adxto AB. In this role, you will be responsible for managing regulatory projects, ensuring compliance with MDR and PMS regulations.
Main Responsibilities:- Manage cross-functional teams to gather regulatory intelligence, facilitating the transition of Legal Manufacturer status for compliance purposes.
- Compile and manage registration dossiers for multiple countries, coordinating with distributors until submission.
- Assist in drafting regulatory submission documents for non-EU markets, handling legalization and apostille processes.
- Verify and update SPOR/PMS product master data, ensuring compliance with regulatory updates.
- Cleanse and complete missing product master data ahead of regulatory deadlines.
The ideal candidate will have strong understanding of MDR regulations and product master data compliance, with experience in dossier compilation and regulatory submission processes.
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Regulatory Affairs Consultant
4 days ago
Stockholm, Stockholm, Sweden Adxto AB Full timeReady to make an impact in regulatory affairs?We are looking for a Regulatory Affairs Consultant for a consulting assignment with a client in the medical device and pharmaceutical industry. The consultant will play a key role in regulatory project clean-up and master data management, ensuring compliance with evolving regulations and supporting regulatory...
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Regulatory Affairs Specialist
6 days ago
Stockholm, Stockholm, Sweden Galderma Full timeGalderma, the emerging pure-play dermatology category leader, is present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology.We are seeking...
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Pharmaceutical Quality Assurance Manager
6 days ago
Stockholm, Stockholm, Sweden Galderma Full timeAt Galderma, we actively seek individuals who focus on getting results, embrace learning, and bring a positive energy. Our ideal candidate will have a strong background in Regulatory Affairs and Quality Assurance, with a good understanding of the pharmaceutical industry across the Nordic country cluster (Sweden, Denmark, Finland, Norway, Iceland).This role...
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Regulatory Affairs Specialist
4 days ago
Stockholm, Stockholm, Sweden Adxto AB Full timeWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Adxto AB. In this consulting assignment, you will play a pivotal role in ensuring regulatory compliance within the medical device and pharmaceutical industry.Key Responsibilities:Collaborate with cross-functional teams to gather regulatory intelligence and facilitate transition...
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Stockholm, Stockholm, Sweden Next Ventures Full time**Job Summary:**We are seeking a seasoned professional to join our team as a D365FO Pharmaceutical Solutions Expert at Next Ventures.In this role, you will be responsible for designing and implementing D365 F&O solutions that meet the unique needs of pharmaceutical manufacturing operations.**Responsibilities:**Develop and execute a comprehensive strategy for...
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Regulatory Compliance Expert
3 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeJob DetailsSobi is a specialized biopharmaceutical company committed to making a positive impact on the lives of patients with ultra-rare diseases. We are seeking a Regulatory Compliance Expert to join our team.About the RoleThis position is responsible for ensuring compliance with GMP & GDP regulations and Sobi's Quality System. The ideal candidate will...
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Sr Director Regulatory Affairs
7 hours ago
Stockholm, Stockholm, Sweden PharmaRelations ApS Full timeConfidentialNordics - StockholmJoin an ambitious team as Senior Regulatory Affairs Director in Stockholm, shaping regulatory strategies and building a new pharma portfolio for a leader in consumer health. Ready to drive impactful change? Apply nowOur client, an innovative leader in the consumer health space, is expanding into the pharmaceutical industry....
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Director of Regulatory Strategy
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Stockholm, Stockholm, Sweden PharmaRelations ApS Full timeRegulatory Affairs Leader Sought for Exciting New VentureJob Summary: We are looking for an accomplished Senior Director Regulatory Affairs to join our team in establishing and leading regulatory strategies for OTC products as we expand into the pharmaceutical industry. This is an excellent opportunity to leverage your expertise and drive meaningful change...
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D365FO Pharmaceutical Solutions Expert
5 days ago
Stockholm, Stockholm, Sweden Next Ventures Full time**Job Description:**We are seeking a highly skilled D365FO Pharmaceutical Solutions Expert to join our team at Next Ventures.The ideal candidate will have extensive experience in designing and implementing D365 F&O solutions for pharmaceutical manufacturing operations. This role involves leading system design, integration, and ensuring compliance with...
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R&D Project Director, BioArctic
2 days ago
Stockholm, Stockholm, Sweden Search4s Dustgoat AB Full timeAre you a seasoned project leader with extensive experience in pharmaceutical drug development? As a senior clinical development lead at BioArctic, you will oversee the entire lifecycle of our neuroscience projects, ensuring timely delivery and strategic alignment with our company goals.About the RoleYou will work closely with internal teams, including...
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Regulatory Affairs Director
4 hours ago
Stockholm, Stockholm, Sweden PharmaRelations ApS Full timeConfidentialNordics - StockholmPioneering Leadership Role in Regulatory AffairsJob Overview: We are seeking a visionary Senior Director Regulatory Affairs to spearhead regulatory strategies and lead the establishment of a new pharmaceutical portfolio for a pioneering company in consumer health. This is an exceptional opportunity to drive impactful change and...
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Regulatory Compliance Officer
3 days ago
Stockholm, Stockholm, Sweden Sobi, Inc Full timeSectors and MarketsThis role involves working with various sectors and markets including pharmaceuticals, biotechnology, and medical devices.Main Responsibilities:Lead quality assurance efforts for Investigational Medicinal Products (IMPs) across multiple markets.Collaborate with regulatory bodies to ensure compliance with relevant regulations.Develop and...
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Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full timeAbout SobiSobi is a global leader in the development and commercialization of innovative treatments for rare and debilitating diseases. Our company operates in over 30 countries, employing over 1,800 talented individuals who share our passion for making a difference.We value diversity and inclusion in our workplace and strive to create an environment that...
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Dermatology Regulatory Consultant
6 days ago
Stockholm, Stockholm, Sweden Galderma Full timeWe are committed to empowering each employee and promoting their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.This role offers a great opportunity to develop your skills and expertise in Regulatory Affairs and...
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Pharmaceutical Quality Lead
3 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeJob SummarySobi is a global biopharmaceutical company transforming the lives of people with rare and debilitating diseases. We are seeking a Pharmaceutical Quality Lead to oversee the quality interface and cross-functional relationships with Sobi stakeholders.About the RoleThis position requires a deep understanding of GMP requirements and experience working...
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Project Management Expert, Biotherapeutics
2 days ago
Stockholm, Stockholm, Sweden Search4s Dustgoat AB Full timeJoin our team as a neuroscientist R&D leadership position and contribute to the development of innovative treatments for neurodegenerative diseases. In this critical role, you will lead cross-functional teams responsible for various neuroscience projects, ensuring timely delivery and strategic alignment with our company goals.About the RoleAs a seasoned...
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Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full timeAbout SobiSobi is a global biopharmaceutical company dedicated to transforming the lives of people with rare and debilitating diseases. Our mission is to provide reliable access to innovative medicines in areas such as haematology, immunology, and specialty care.As a key player in the industry, we are committed to our core values: Care, Ambition, Urgency,...
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Senior Regulatory Professional
4 hours ago
Stockholm, Stockholm, Sweden PharmaRelations ApS Full timeNordics - StockholmStrategic Regulatory Affairs Expert WantedCompany Overview: A leading player in the consumer health market is expanding into the pharmaceutical industry. To support this growth, we seek a seasoned Senior Director Regulatory Affairs to oversee regulatory activities across various areas, including MA submissions and marketing...
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Regulatory Compliance Manager
7 hours ago
Stockholm, Stockholm, Sweden Xoala Full timeXoala is a leading provider of payment solutions, committed to streamlining global finances by empowering businesses with innovative, secure, and efficient financial services. Xoala offers an all-in-one platform that allows you to handle international transactions, manage accounts in multiple currencies, and process payments securely—no matter where in the...
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Senior Regulatory Manager
13 hours ago
Stockholm, Stockholm, Sweden PharmaRelations ApS Full timeAbout the RoleWe are seeking a Sr. Regulatory Manager to support our Global Regulatory Affairs team in the EU. The successful candidate will ensure that product information complies with local regulatory requirements and global labeling procedures.In this role, you will also be responsible for performing timely development/revision of new/existing packaging...