CMC Documentation Expert

Job DescriptionYou will be working in the Regulatory CMC team at our Head Office. The team consists of 11 employees who are part of Global Regulatory Affairs.In this role, you will be responsible for:Preparing regulatory CMC documentation and handling submissions to authorities globally.Scientific/technical writing and maintaining regulatory CMC...

At ALK, we are a global pharmaceutical company specialized in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an open-minded approach, and contributing to an inspiring and fun working environment together with our colleagues.Global Regulatory Affairs at ALKOur team provides a uniquely dynamic and pleasant work environment,...

Global Regulatory Opportunities ">Are you interested in the intersection of scientific and regulatory affairs? Do you thrive in discussions on complex chemistry, manufacture, and control (CMC) activities?">About the Role">You will join the Global Regulatory CMC team at ALK-Abello, contributing to the development and submission of strategic tablet products...

Welcome to a career-defining opportunity as a Principal Scientist for process development at ALK, where you will be at the forefront of developing and optimizing manufacturing processes for protein extracts.Our team in Drug Substance Development is responsible for the development and optimization of manufacturing processes for protein extracts. We work...

About the Role:">We are seeking a highly skilled Regulatory Chemistry and CMC expert to join our team based at our Head Office in Hørsholm.

Job Opportunity: Developing Allergen Extract Manufacturing Processes">We are seeking a Senior Research and Development Specialist to join our team in the Drug Substance Development department of Pharmaceutical Development.The successful candidate will be responsible for designing, executing, and reporting development studies, including CMC documentation....

Unlock Your Potential in a Dynamic TeamWe are seeking a highly skilled Principal Scientist to join our Drug Substance Development department at ALK-Abello. As a key member of our team, you will be responsible for the development and optimization of manufacturing processes for allergen extracts.About the RoleIn this challenging and rewarding role, you will...

At Epista, we're expanding our team of experts in Computer System Validation (CSV) and transitioning to Computer Software Assurance (CSA). This shift towards CSA is driven by the FDA's recommendations and the new GAMP edition. As a CSV consultant, you'll play a crucial role in helping Life Science companies adapt to these changes and maintain...

At Novonesis, we are driving innovation in the field of biology to address humanity's biggest challenges. Our mission is rooted in the understanding that solutions grounded in biology have the potential to revolutionize various aspects of our lives.We are seeking a highly skilled and experienced Senior Integration Developer to join our Agile Integration...

About GubraGubra is a leading pharmaceutical company specializing in drug discovery and development. Our mission is to deliver innovative solutions that improve human health.Role SummaryWe are seeking an experienced Laboratory Technician to join our Preformulation Team within the Drug Profiling department. As a key member of our team, you will be responsible...

At Epista Life Science, we specialize in business process and IT services for the Life Sciences industry. With extensive experience working with legacy systems and navigating complex regulatory requirements, our team has developed a deep understanding of the challenges facing companies in this sector.The new Computer Software Assurance (CSA) guidelines and...

We are seeking a highly motivated and detail-oriented Mechanical Engineering Product Development Assistant to join our R&D Hardware team at Trackman.The ideal candidate will have a strong background in mechanical engineering, experience with CAD programs, and a passion for product development. As a member of our team, you will play an instrumental role in...

Do you have interest in regulatory chemistry, manufacture and control (CMC) activities for strategic tablet products registered globally? Do you thrive in scientific discussions on complex scientific matters? Are you experienced working with regulatory CMC submissions to the authorities globally? The position You will join the Regulatory CMC, Tablets and...

Do you have interest in regulatory chemistry, manufacture and control (CMC) activities for strategic tablet products registered globally? Do you thrive in scientific discussions on complex scientific matters? Are you experienced working with regulatory CMC submissions to the authorities globally? The position You will join the Regulatory CMC, Tablets and...

Medical Device Engineer for Device Development and Support in Global CMC Development Do you have knowledge within development of drug-device combination products? Are you perceived as a structured and constructive person with excellent collaboration skills? Would you like to contribute to the quality of life for people with allergy? You might then be the...

Principal Scientist for process development Would you like to work in a dedicated team responsible for development of allergen extract manufacturing processes? Do you like to design laboratory studies and help carry them out in close collaboration with skilled technicians? Do you have experience with protein extraction, microfiltration, dia/ultrafiltration...

Would you like to work in a dedicated team responsible for development of allergen extract manufacturing processes? Do you like to design laboratory studies and help carry them out in close collaboration with skilled technicians? Do you have experience with protein extraction, microfiltration, dia/ultrafiltration and separation methods? The position Drug...

Are you a young Scientist with flair for IT systems and analytical instruments, curious to learn how to qualify analytical instruments and implement new robotic solutions? ALK is a global allergy solution company that offers a wide range of allergy treatments, products, and services to meet the needs of those who suffer from allergies. We are in search of a...

Scientist for instrument qualifications in Laboratory Automation Development Are you a young Scientist with a flair for IT systems and analytical instruments, curious to learn how to qualify analytical instruments and implement new robotic solutions? ALK is a global allergy solution company that offers a wide range of allergy treatments, products, and...

With the new GAMP edition and recommendations from the FDA, it is now clear that the Life Science industry is moving away from CSV and confidently towards Computer Software Assurance (CSA). That means that more and more companies will need help transitioning their efforts to meet updated best practice standards. Epista’s team of experts have an abundance...

A Change & Release Manager’s main goal is to ensure effective system changes by establishing and facilitating a process that maximizes the number of successfully implemented IT changes. Due to industry requirements for stable and high performing production in an increasingly dynamic environment, it is critical to be able to deliver frequently while...

Trackman is looking for a Junior Hardware Engineer We offer an exciting opportunity in our R&D hardware team. At Trackman we are growing, as we are constantly striving to develop, produce and deploy our market leading sport tracking solutions within golf, baseball, football and more. Our innovative products are based on multi sensor technology including...

Trackman is looking for a Senior Optical Engineer We offer an exciting opportunity in our R&D hardware team. At Trackman we are growing, as we are constantly striving to develop, produce and deploy our market leading sport tracking solutions within golf, baseball, football and more. Our innovative products are based on multi sensor technology including...

R&D Hardware Student Assistant – Mechanical Engineering Are you a master’s in engineering student (or final year bachelor’s) and are you passionate about product development? Are you structured and a strong relationship builder? Are you curious, eager to learn, and want to have an impact on your job and surroundings? Then you might be our new student...