Global Regulatory CMC Lead - Stockholm

The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets in development, prepares CMC sections of IND/IMPD, MAA, NDA/BLA as well as assesses global filing strategy for post approval changes. · ...

We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. · Competitive compensation for your work · Emphasis on work/life balance · Collaborative and team-oriented environment · ...

+Job summary · Karo Healthcare is a dynamic and growing personal-care retail company that empowers people to make intelligent health decisions. · +Responsibilities · Lead the end-to-end execution of CMC projects for topical and oral solid dosage forms — from formulation and proce ...

Karo Healthcare is looking for a CMC Development Manager to join their fast-moving international team in Stockholm or Copenhagen. As a key technical leader, you'll take full ownership of CMC activities from concept to commercialization. · Key responsibilities include leading end- ...

This is the opportunity for you to play a key role in bringing innovative therapies to patients by leading CMC projects. · Lead and execute CMC activities supporting product development regulatory variations approvals and launches across multiple territories · Manage CMC project ...

As Associate Director within Project Management you will be responsible for the direction implementation control and completion of CMC projects from early development through launch and beyond while ensuring alignment with company strategy commitments and goals. · ...

This role will oversee outsourced pharmaceutical development clinical manufacturing preparations for commercial manufacturing and supply activities performed at CDMOs for designated projects. · You will manage activities performed both internally and through external experts ensu ...

We are looking for a Senior Cable Harness Engineer to support an exciting new deployment based in Stockholm, Sweden. · Strong experience in mechanical design of cable harness routing and installation · Solid experience working with CATIA V5 (mandatory) · ...

We are looking for an experienced Senior Software Engineer/Technical Lead to join a Stockholm-based product team working on a mission-critical Windows application used by customers in regulated environments. · 5+ years of experience in software development · Strong skills in C# / ...

We have a consulting assignment available for a Hardware Engineer to work on a project in Stockholm. · Finding necessary components · Designing using Altium Or Cadence tool · Conducting simulations in various different tools and building prototypes in customers lab. · ...

Job summaryAbout Calliditas Therapeutics is a biopharmaceutical company focused on identifying developing and commercializing novel treatments in orphan indications with significant unmet medical needs. They are building a world-class team committed to advancing science and deliv ...

About Calliditas Therapeutics · Clinical and Commercial Manufacturing Manager will be responsible for direction of CMC projects from early development to launch. This role oversees outsourced pharma dev, · clinical manufacturing, · preparations for commercial manufacturing and su ...

We are looking for a Senior Scientist Analytical Technology who will play a key role in ensuring robust analytical control, regulatory compliance, and continuous improvement across our product portfolio. · ...

As a Senior Process Manager for Manufacturing Science and Technology (MS&T), you will play a pivotal role in ensuring the compliant, reliable, and sustainable manufacturing of Sobi's clinical and commercial products. · ...

Do you thrive at the intersection of pharmaceutical development, manufacturing, and supply chain? Do you want to play a key role in bringing innovative therapies to patients by leading CMC projects? · About Calliditas TherapeuticsCalliditas Therapeutics is a biopharmaceutical com ...

Cable harness engineer to support an exciting new deployment based in Stockholm. · ...

We are seeking a Senior Process Manager to join our Manufacturing Science and Technology (MSAT) team within the Global CMC, Science & Technology Department (GCSAT). As a key member of our team, you will be responsible for ensuring the compliant, reliable, and sustainable manufact ...

Affibody is a clinical stage radiopharmaceutical company developing next generation Radioligand Therapies (RLTs) designed to deliver highly selective tumor targeting across a wide range of cancers. · We are now looking for an additional CMC Project Manager who will coordinate com ...

We are looking for an experienced Senior Software Engineer/Technical Lead to join a Stockholm-based product team working on a mission-critical Windows application used by customers in regulated environments. · This is a hands-on role where you will combine modern software develop ...

We have a consulting assignment available for a Hardware Engineer to work on project in Stockholm. Your role will consist of working on complex systems towards high speed digital design and power design. · Finding necessary components · Designing using Altium Or Cadence tool · Co ...