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Biopharma Regulatory Professional
12 hours ago
- Develop and implement regulatory strategies for CMC-related submissions (IND, CTA, RtQ etc.) for FDA, EMA, and national authorities in third world countries.
- Collaborate with subject matter experts (SMEs) to develop regulatory documents related to manufacturing (e.g. IMPD, Module 3, Briefing Document).
- Coordinate and compile regulatory submissions, ensuring timely delivery and high-quality output.
The Regulatory Affairs Manager will report directly to the VP of Regulatory Affairs at Scandinavian Biopharma.
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Regulatory Affairs Specialist
12 hours ago
Stockholm, Stockholm, Sweden Scandinavian Biopharma Full timeCompany OverviewScandinavian Biopharma is a leading research-based specialty biopharma company dedicated to improving human health worldwide. We are committed to developing innovative solutions for unmet medical needs, with a focus on vaccines and immunoglobulins.Our team has extensive experience in vaccine development, manufacturing, registration, and...
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Regulatory Compliance Manager
12 hours ago
Stockholm, Stockholm, Sweden Scandinavian Biopharma Full timeAbout the Company CultureWe are a dynamic and stimulating work environment, with a strong focus on collaboration and teamwork. Our team is dedicated, experienced, and friendly, with an exciting journey ahead.We value service-minded professionals who can work proactively and independently. If you are looking for a challenging and rewarding role in Regulatory...
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Biopharma Regulatory Manager
12 hours ago
Stockholm, Stockholm, Sweden Qrios Minds AB Full timeAt Qrios Minds AB, we are developing the first vaccine against ETEC, a bacteria causing diarrhea in travelers and endemic populations. We are seeking a highly skilled Regulatory Affairs Manager to join our team.This role offers the opportunity to apply your regulatory expertise within multiple areas during development, focusing on regulatory CMC. You will...
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Regulatory Expert for Scandinavian Biotech
12 hours ago
Stockholm, Stockholm, Sweden Qrios Minds AB Full timeWe are an exciting research-based specialty biopharma company determined to give people all over the world a longer and better life. Our goal is to develop innovative solutions for unmet medical needs.As a Regulatory Affairs Manager at Qrios Minds AB, you will play a crucial role in ensuring compliance with regulatory requirements and guidelines.Your...
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CMC Regulatory Expert
12 hours ago
Stockholm, Stockholm, Sweden Scandinavian Biopharma Full timeAbout the PositionThe Regulatory Affairs Manager will be responsible for coordinating the regulatory strategy for the development and implementation of changes in the manufacturing process, including changes in the manufacturer (drug substance and drug product).The ideal candidate will have excellent communication skills in speech and writing, with...
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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 Affairs Professional
5 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeJob RequirementsTo be successful in this role, you will need:Qualifications:Degree in aviation management, engineering, law, or a related field.2-5 years of experience in regulatory compliance within the aviation sector.In-depth knowledge of relevant aviation regulations and standards (EASA regulations).Skills:Strong analytical skills and attention to...
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Regulatory Affairs Professional
2 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeKey Responsibilities:">The successful candidate will be responsible for:">">Implementing and monitoring the local Compliance Programme.">Providing timely and accurate advice to internal and external stakeholders on compliance matters.">Working closely with other control functions to identify key control issues and ensure adequate controls are put in...
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Safety and Regulatory Affairs Professional
3 days ago
Stockholm, Stockholm, Sweden Ericsson AB Full timeEricsson AB is seeking a highly skilled Regulatory Compliance Engineer for Emerging Technologies to join our team. In this role, you will play a critical part in ensuring the safety and regulatory compliance of our products, working closely with cross-functional teams to achieve these objectives.The ideal candidate will have a strong background in data...
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Regulatory Affairs Expert
12 hours ago
Stockholm, Stockholm, Sweden Kenvue Full timeKenvue is a leading consumer healthcare company with a rich heritage and a passion for science. As Senior Regulatory Affairs Manager, you will be responsible for ensuring the success of new product registrations, line extensions, and new indications and claims in alignment with the business plan, while maintaining compliance for all products with local...
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Head of Regulatory Operations
12 hours ago
Stockholm, Stockholm, Sweden Kenvue Full timeKenvue is proud to offer a competitive Total Rewards Package to attract and retain top talent in the field of Regulatory Affairs. We are looking for a Head of Regulatory Operations who will be responsible for leading the Regulatory Affairs team to achieve affiliate regulatory objectives.The ideal candidate will have experience in cultivating and leveraging...
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Regulatory Affairs Professional
12 hours ago
Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full timeSenior RA Specialist Med TechThis is an outstanding chance to contribute to the success of an innovative Swedish medtech company at a pivotal time in its evolution.Responsibilities:Establish and implement effective regulatory strategies for medical devices across their entire lifecycle.Collaborate closely with license partners to address regulatory matters,...
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Regulatory Affairs Specialist
2 days ago
Stockholm, Stockholm, Sweden Albion Rye Associates Full timeWe are on the hunt for a seasoned professional to fill the role of Regulatory Affairs Specialist at Albion Rye Associates. This position requires an individual who is passionate about regulatory compliance and has a proven track record in ensuring seamless operations within the biotech and pharmaceutical industries.Main responsibilities include: Developing...
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Financial Services Regulatory Professional
6 days ago
Stockholm, Stockholm, Sweden FNZ Full timeRisk Governance and ComplianceAs a Risk Officer, you will play a critical role in ensuring the effective governance and compliance of risk management practices within our organization.Some of your key responsibilities will include:Developing and maintaining risk management frameworks and policies that align with industry best practices and regulatory...
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Regulatory Affairs Manager
6 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 Strategy Manager
3 days ago
Stockholm, Stockholm, Sweden Chiesi Farmaceutici S.p.A. Full timeAbout the RoleWe 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...
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Regulatory Affairs Leader
2 days ago
Stockholm, Stockholm, Sweden Kenvue Full timeAt Kenvue, we are passionate about everyday care. Our commitment to science-driven innovation has enabled us to become the house of iconic brands - Neutrogena, Aveeno, Tylenol, Listerine, Johnson's, and BAND-AID Brand Adhesive Bandages.As Senior Manager of Regulatory Affairs (Nordics), you will lead our team in achieving regulatory excellence across new...
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Regulatory Lead
12 hours ago
Stockholm, Stockholm, Sweden Chiesi Farmaceutici S.p.A. Full timeAre you a seasoned regulatory affairs professional looking for a challenging role that will allow you to grow and develop your skills?Chiesi Farmaceutici S.p.A. is a leader in the pharmaceutical industry, and we are seeking a talented Senior Regulatory Affairs Manager to join our team in Stockholm, Sweden.This role offers the opportunity to work on a wide...
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Global Regulatory Strategy Lead
6 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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Senior Regulatory Affairs Manager
12 hours ago
Stockholm, Stockholm, Sweden Chiesi Farmaceutici S.p.A. Full timeAs a key member of Chiesi's Global Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory standards and guidelines.You will work closely with cross-functional teams, including R&D, Clinical Development, and Quality Assurance, to ensure that regulatory strategies are aligned with business objectives.This role requires a deep...