Regulatory Publishing Specialist
6 days ago
As a Senior Regulatory Publisher & Submission Manager at Macure Pharma, you will play a key role in shaping regulatory processes and implementing our new Submission Publishing Tool.
Your responsibilities will include:
- Compiling, formatting, and validating regulatory submissions in eCTD.
- Implementing and optimizing our digital document management system to streamline workflows and ensure operational excellence.
- Developing and maintaining Standard Operating Procedures (SOPs) to ensure regulatory compliance and process efficiency.
- Supporting submission processes for National, MRP, and DCP procedures, as well as regulatory lifecycle management and interactions with CMOs, external partners, and health authorities.
This is an exciting opportunity to join a dynamic team and shape the future of regulatory operations at Macure Pharma.
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Regulatory Affairs Specialist
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Copenhagen, Copenhagen, Denmark Macure Pharma Full timeAt Macure Pharma, we are seeking a seasoned Regulatory Affairs Specialist to join our team. This role offers an exciting opportunity to shape regulatory processes in a fast-growing company and play a key role in the implementation of our new Submission Publishing Tool.Key Responsibilities:Compiling, formatting and validating regulatory submissions in eCTD...
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Publisher & Submission Manager
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Copenhagen, Copenhagen, Denmark Macure Pharma Full timeMacure Pharma is seeking a Publisher & Submission Manager to join our Regulatory Affairs team. In this role, you will be responsible for compiling, formatting, and validating regulatory submissions in eCTD format. You will also play a key role in the implementation of our new Submission Publishing Tool, leveraging your expertise in EDMS systems and workflow...
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Senior Regulatory Expert
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Senior Regulatory Affairs Manager
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Copenhagen, Copenhagen, Denmark Macure Pharma Full timeWe are seeking a highly experienced Regulatory Publisher & Submission Manager to join our Regulatory Affairs Team in Copenhagen or Malta.As a key member of our team, you will be responsible for:Regulatory publishing: compiling, formatting, and validating regulatory submissions in eCTD.System implementation: playing a key role in the implementation of our new...
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Regulatory Compliance Lead
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Digital Regulatory Operations Lead
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