Regulatory Strategy Manager
2 days ago
We are seeking a highly experienced Senior Global RA Manager to join our dynamic team in Stockholm. As a key contributor to Chiesi's growth strategy, you will lead the Global Regulatory Team and serve as the regulatory representative on global core teams for assigned projects.
Key Responsibilities:
- Develop and implement global/regional regulatory strategies for new and existing products, ensuring timely and accurate submissions.
- Manage and review regulatory applications, reports, and correspondence to ensure compliance with internal and external regulatory standards.
- Cultivate strong relationships with health authorities, leveraging your knowledge of regulations and requirements to drive project success.
- Support affiliates and partners on prioritized issues and topics, providing strategic guidance to R&D functions and key stakeholders.
Requirements:
- At least ten years of experience within Regulatory Affairs, with at least five in a regional or global context.
- University degree in a scientific discipline, such as Chemistry, Pharmacy, Human Medicine, Biological Science, or Biotechnology.
- Written and spoken English for professional purposes.
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Stockholm, Stockholm, Sweden Qrios Minds AB Full timeJob Title: Regulatory Affairs ManagerWe are seeking a highly motivated and experienced Regulatory Affairs Manager to join our team at Qrios Minds AB. In this role, you will play a critical part in developing and implementing our regulatory strategy, ensuring the compliance of our biopharmaceutical products with regulatory requirements.Responsibilities:*...
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Regulatory Strategy Development Expert
5 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeWe are seeking a highly skilled Regulatory Affairs Manager to join our team at TN Sweden. The successful candidate will have a strong background in regulatory affairs and excellent communication skills. As a key member of the Medical department, you will support the organization with strategic regulatory knowledge and assist in developing standards for...
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Global Regulatory Strategy Lead
5 days ago
Stockholm, Stockholm, Sweden Haeger & Carlsson | Executive Search & Interim AB Full timeExecutive Search & Interim AB - Partnering with Haeger & CarlssonWe are seeking a seasoned Regulatory Affairs Director to join our client's dynamic team. In this pivotal role, you will drive global regulatory strategies to ensure the timely submission and approval of biologic products.The successful candidate must have a strong background in regulatory...
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Regulatory Affairs Manager
5 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeAre you a driven and detail-oriented professional with expertise in navigating the complex landscape of regulatory compliance?TN Sweden is expanding its Medical department, and we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key function within the department, this role will support the organization with strategic regulatory...
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Regulatory Compliance Manager
4 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeAs a Regulatory Compliance Manager at TN Sweden, you'll be responsible for ensuring our business operates within the bounds of regulatory requirements. You'll identify, advise, and evaluate compliance risks, and develop strategies to mitigate potential issues.About the RoleThis is an exciting opportunity to join our Conduct, Advisory and Products Compliance...
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Director Regulatory Affairs Manager
5 days ago
Stockholm, Stockholm, Sweden Haeger & Carlsson | Executive Search & Interim AB Full timeHaeger & Carlsson Executive Search & Interim ABWe are partnering with a renowned life sciences company to find a highly skilled Director Regulatory Affairs. As a key member of the leadership team, you will develop and execute global regulatory strategies to support the submission and approval of biologics.The ideal candidate has a proven track record in...
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Labeling Regulatory Affairs Manager
1 day ago
Stockholm, Stockholm, Sweden Sobi Full timeJob OverviewThe Global Labeling Operations Lead plays a critical role in coordinating and managing activities related to the approval and maintenance of printed labeling components.Key Responsibilities:Project Management: Manage labeling and packaging artwork projects affecting multiple products to ensure timely delivery.Lifecycle Management: Coordinate...
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Senior Manager, Regulatory Affairs Lead
5 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeAbout the RoleSenior Manager, Regulatory SciencesProPharma Group is a global leader in regulatory sciences, providing expert advice and solutions to biotech, med device, and pharmaceutical organizations.Key ResponsibilitiesLead client projects, ensuring efficient project execution and contributing to larger projects.Author global nonclinical/clinical aspects...
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Stockholm, Stockholm, Sweden Qrios Minds AB Full timeCompany Overview:Qrios Minds AB is a research-based specialty biopharma company committed to delivering innovative solutions that improve people's lives worldwide. Our mission is to develop groundbreaking treatments that address unmet medical needs.Job Summary:We are seeking a talented Regulatory Affairs Manager to join our team. In this exciting role, you...
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Regulatory Compliance Specialist
5 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeWe are looking for a Regulatory Affairs Manager who can lead our efforts in regulatory strategy development, policy monitoring, and cross-functional collaboration. The successful candidate will have a strong background in regulatory affairs and excellent communication skills.The role reports to the Head of Regulatory Affairs, Quality Assurance, and...
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Stockholm, Stockholm, Sweden TN Sweden Full timeWe are seeking a highly experienced and skilled Senior Project Manager to lead and identify regulatory projects with high complexity across Product Management Transaction Banking (TxB) Product Management.About the RoleThis role is responsible for managing multiple projects simultaneously, ensuring timely delivery of complex regulatory changes related...
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Stockholm, Stockholm, Sweden TN Sweden Full timeWe are seeking a highly experienced Project Director to lead and manage complex regulatory change management projects within the Transaction Banking unit.About the RoleThe successful candidate will be responsible for developing and implementing project plans, timelines, and budgets, while ensuring timely delivery of complex regulatory changes related...
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Senior Regulatory Affairs Manager Nordics
7 days ago
Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full timeWe are looking for a highly motivated and experienced Senior Regulatory Affairs Manager to join our team in the Nordics. As part of the EU Regulatory Affairs team, you will be responsible for post-approval/life-cycle Regulatory activities in the Nordic markets (Sweden, Norway, Finland, Denmark, Iceland) for our company's Nordic portfolio.You will act as...
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Regulatory Affairs Manager
6 days ago
Stockholm, Stockholm, Sweden Albion Rye Associates Full timeWe are seeking a skilled Business Development Manager to drive business growth and success in the biotech regulatory space. As a key member of our team, you will be responsible for identifying, developing, and closing new business opportunities that align with our company's goals and objectives.About UsAlbion Rye Associates is a leading consultancy that...
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Clinical Strategy Manager
2 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeJob Title:Clinical Strategy ManagerAbout the Role:We are seeking an experienced clinical professional to join our team as a Clinical Strategy Manager. As a key member of our product management team, you will be responsible for developing and executing clinical strategies to support the launch and growth of our ventilation platform.Key...
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Compliance Officer Regulatory Affairs
5 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeAs a Regulatory Affairs Manager at TN Sweden, you will play a key role in ensuring the company's compliance with regulatory requirements. Your expertise in regulatory strategy development, policy monitoring, and cross-functional collaboration will enable us to maintain high standards of quality and patient safety.You will work closely with the Head of...
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Freight Technology Regulatory Specialist
4 days ago
Stockholm, Stockholm, Sweden Einride Full timeEinride is a pioneer in the autonomous and electric transportation sector, providing freight capacity as a service that accelerates the world toward sustainability goals.As Regulatory Affairs Manager, you'll play a crucial role in developing and executing Einride's regulatory strategy, positioning us as the leader in Autonomous freight technologies.Key...
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Development Regulatory Affairs Expert
5 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeJob SummaryProPharma Group is seeking a Senior Manager, Regulatory Sciences to lead client projects, ensuring efficient project execution and contributing to larger projects.ResponsibilitiesProject manage assigned projects, including approval of time entry and invoicing, budget monitoring, and client liaison.Provide expert guidance and technical expertise,...
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Regulatory Affairs Leader
2 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeKaro Healthcare is a dynamic and growing company focused on making smart choices for everyday healthcare. We own and sell over 80 brands in about 90 countries.Job OverviewWe're looking for a highly skilled Regulatory Affairs Leader to join our headquarters in Stockholm, Sweden. This individual will be responsible for leading the Submissions & Compliance team...
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Regulatory Affairs Director
4 days ago
Stockholm, Stockholm, Sweden Einride Full timeAt Einride, we're reshaping the future of transportation by harnessing cutting-edge autonomous and electric technologies to provide freight capacity as a service. This accelerates the world toward our shared sustainability goals.Founded in Sweden in 2016, Einride became the first company to deploy a cab-less autonomous electric heavy-duty vehicle on a public...