Vaccine Regulatory Specialist
13 hours ago
Scandinavian Biopharma is a dynamic and innovative company dedicated to developing life-changing treatments for people worldwide. As a Regulatory Affairs professional, you will play a critical role in ensuring the quality and compliance of our vaccine products.
About the Company- We are a research-based specialty biopharma company with a strong focus on vaccine development and distribution.
- We have a senior commercial team with over 20 years of experience in biotech, big pharma, and medtech industries.
- We are well-funded, thanks to support from EU strategic research foundations, PATH, USAMMDA, and our own distribution activities.
- Develop and implement regulatory strategies for CMC changes, including updates to manufacturing processes and vendors.
- Collaborate with subject matter experts to create high-quality regulatory documents, such as IMPDs and briefing documents.
- Prioritize and coordinate submissions to regulatory authorities, including FDA, EMA, and national agencies in emerging markets.
The ideal candidate will possess strong analytical and problem-solving skills, with the ability to communicate effectively and work collaboratively within cross-functional teams.
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CMC Regulatory Expert
13 hours ago
Stockholm, Stockholm, Sweden Scandinavian Biopharma Full timeWe are seeking an experienced Regulatory Affairs professional to join our team at Scandinavian Biopharma. As a key player in our company's growth strategy, you will be responsible for ensuring the regulatory compliance of our vaccine products.Job DescriptionCoordinate regulatory activities related to CMC changes, including updates to manufacturing processes...
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Regulatory Affairs Lead
13 hours ago
Stockholm, Stockholm, Sweden Scandinavian Biopharma Full timeAt Scandinavian Biopharma, we are committed to delivering life-changing treatments to people worldwide. As a key member of our team, you will play a pivotal role in ensuring the regulatory compliance of our products, particularly vaccines and biologics.Main ResponsibilitiesDevelop and implement regulatory strategies for CMC changes, including updates to...
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Regulatory Affairs Specialist
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Biopharma Compliance Manager
13 hours ago
Stockholm, Stockholm, Sweden Scandinavian Biopharma Full timeWe are looking for an experienced Regulatory Affairs professional to join our team at Scandinavian Biopharma. As a key member of our team, you will be responsible for ensuring the regulatory compliance of our vaccine products.ResponsibilitiesDevelop and implement regulatory strategies for CMC changes, including updates to manufacturing processes and...
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Financial Regulatory Compliance Specialist
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Chemical Regulations Specialist
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