Publisher & Submission Manager

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...

We 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...

We are looking for a Senior Regulatory Expert to join our team at Macure Pharma. As a key member of our Regulatory Affairs department, you will be responsible for implementing and optimizing our new Submission Publishing Tool. Your expertise in eCTD publishing and regulatory submission workflows will be instrumental in shaping our digital regulatory...

We are looking for a Regulatory Compliance Lead to join our team at Macure Pharma. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines. Your expertise in eCTD publishing and regulatory submission workflows will be instrumental in shaping our digital regulatory...

Mature, niche hospital products company focusing on pharmaceutical manufacturing seeks a skilled Regulatory Publisher & Submission Manager.Responsibilities include:Compiling, formatting, and validating regulatory submissions in eCTD.Developing and maintaining SOPs to ensure regulatory compliance and process efficiency.Supporting submission processes for...

At 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...

Oresund Pharma ApS is a dynamic and ambitious company seeking a talented Global Regulatory Manager to join our Regulatory department.In this role, you will be responsible for ensuring that our products comply with regulatory requirements and commercial demands worldwide. This includes managing regulatory submissions, establishing relationships with...

We are seeking a highly motivated and experienced Regulatory Project Manager to join our team at Genmab. As an Associate Director, Global Regulatory Affairs Project Lead, you will be responsible for ensuring regulatory compliance and oversight for our clinical trials, as well as developing and executing EU/ROW strategies for assigned projects.In this role,...

As our Senior Manager EU/ROW Regulatory Affairs, you'll be responsible for ensuring that our regulatory affairs functions are operating effectively and efficiently. This includes representing RA in clinical trial teams, ensuring regulatory oversight and progress of multiple clinical trial submission activities, and representing EU/ROW in the Global...

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. Are you passionate about driving business success through strategic...

Job ResponsibilitiesThe successful candidate will be responsible for:Developing and executing bid strategies, ensuring alignment with customer requirements and company goals.Coordinating with internal teams (engineering, finance, legal, procurement) to create compelling, competitive, and compliant bids.Managing timelines, budgets, and resources for each bid,...

A M&A/Transactional Risk Underwriter is needed to join our team in Copenhagen. The successful candidate will be responsible for assessing and underwriting insurance submissions to ensure compliance with legal and regulatory requirements.The ideal candidate will have a strong understanding of Transactional Risk Insurance principles and the ability to work...

Join Black Swans Exist, a pioneer in microbiome-based therapies for women's reproductive health, as a Director of Regulatory Affairs. This pivotal role demands a visionary leader who can drive global regulatory strategies and navigate complex regulatory landscapes.About the PositionIn this high-stakes position, you will oversee the development and approval...

Job Description:The Senior Regulatory Lead EU/ROW will be responsible for ensuring regulatory oversight and progress of clinical trial submissions in the EU/ROW region. This role will represent RA in the Clinical Trial Teams and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.Key Responsibilities:Represent...

Pursue a career-defining opportunity as a Strategic Regulatory Leader with Black Swans Exist. Our clinical-stage biotech company is pushing the boundaries of microbiome-based therapies for women's reproductive health.About the JobAs a key member of our team, you will develop and execute global regulatory strategies, driving the approval of innovative...

Job DescriptionAenu VC is a globally active company with a passion for making EV charging simple, accessible, and reliable for everyone.We are looking for a talented Bid Manager to join our team and help us achieve our mission.Your key outcomes will be:Measurable efficiency in the bids we choose to engage on, both in ARR won and time spentImproved response...

Role SummaryThis Senior Bid Manager role is responsible for driving the success of our proposals and growth process by securing new key client contracts. You will work closely with the Nordic Business Development Lead and Client Partners to support the development of cohesive and competitive bids.Key SkillsEnd-to-end bid management: Proven ability to manage...

About the Role:The Associate Director Regulatory Strategy will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects. This role will represent EU/ROW in the Global Regulatory Team(s) and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.Key Responsibilities:Develop...

Qualifications and SkillsTo succeed in this role, you should have:A relevant academic degree, preferably a M.Sc. or Ph.D. in mechanical, biomedical, or pharmaceutical engineering5-10 years of experience within the development of drug delivery solutions for drug-device combination productsExperience with medical device design control, packaging and labelling...

We are seeking an experienced profile to join our design studio in Copenhagen. In this role, you will play a key part in generating, securing, prioritizing, and winning projects that position Henning Larsen as a leading international design studio globally. As we grow, we need your expertise to help us proactively secure new opportunities, forge successful...