Regulatory Affairs 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...

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.

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...

Product Regulatory ExpertWe are seeking a Product Regulatory Expert to support the development of regulatory compliant and technically relevant solutions.About the RoleThe position is part of the Regulatory Intelligence & Conformity (RIC) Team at VELUX Group, focusing on ensuring the long-term technical and regulatory relevance of our product offerings.Your...

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,...

At Velux Deutschland GmbH, we offer a world of opportunities and the chance to shape a bright future. As a leader in sustainable living solutions for indoor spaces, we empower people to transform their rooms and lead a healthier daily life with more daylight and fresh air.We are an international family-owned company with strong financial roots, and every...

Key Responsibilities:Prepare and handle regulatory CMC documentation for submissions to authorities globally, ensuring compliance with relevant regulations and guidelines.Develop and maintain regulatory CMC documentation for initial and life cycle submissions for strategic products, collaborating with cross-functional teams to ensure seamless...

About the RoleWe are seeking a visionary leader to spearhead our medical writing and clinical reporting function. As Director for Clinical Reporting, you will lead a team of 7 dedicated professionals, responsible for the global medical writing and clinical reporting function.Your key responsibilities will include:Team Leadership: Manage the Clinical...

About the RoleWe are seeking an experienced Clinical Reporting Team Lead to join our team at ALK. The successful candidate will be responsible for leading a global medical writing and clinical reporting function.This is a fantastic opportunity to take on a leadership role in a dynamic and growing organization, working closely with cross-functional teams to...

About ALK-AbellóALK-Abelló is a leading pharmaceutical company dedicated to improving the lives of people suffering from allergies. Our mission is to create innovative solutions that make a meaningful difference in the world.We are seeking an experienced Portfolio Management Lead to join our New Product Planning and Portfolio Strategy team. In this role,...

Drive Clinical Reporting ExcellenceWe seek an exceptional leader to join our Clinical Reporting team as Director for Clinical Reporting at ALK-Abello. This individual will lead a team of experienced medical writers and be responsible for the global medical writing and clinical reporting function.Your Key Responsibilities Will Be:To manage the Clinical...

Lead a Team of Medical WritersAs the Director for Clinical Reporting at ALK-Abello, you will oversee a team of 7 dedicated employees responsible for global medical writing and clinical reporting. Your leadership skills will be instrumental in ensuring the success of this function.Your Responsibilities Will Include:Managing the Clinical Reporting team to...

Velux Group: A Pioneer in Sustainable Built EnvironmentAt Velux Group, we strive to create a world of possibilities by providing innovative solutions that promote a healthy and sustainable living environment. Our commitment to excellence is reflected in our strong economic foundation, which enables us to reinvest in our employees, the planet, and the...

About UsALK-Abelló A/S is a leading global allergy solution company, dedicated to developing innovative treatments, products, and services for individuals suffering from allergies. Our mission is to provide exceptional solutions that improve the lives of our customers. We pride ourselves on our commitment to quality, integrity, and customer satisfaction....

Company OverviewThe VELUX Group is an international, family-owned business with strong financial roots. We offer a world of opportunities and the chance to create a bright future in the sustainable indoor living industry.

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...

Company OverviewALK-Abelló A/S is a global allergy solution company offering a wide range of allergy treatments, products, and services. Our mission is to provide innovative solutions for those suffering from allergies. Job DescriptionAs a Senior Scientist in Laboratory Automation Development, you will be part of Analytical Development consisting of 40...

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...

Are you passionate about leadership and bringing out the best in other people? Do you have an innovative mindset that drives change in a fast-changing environment? Do you like working with engaged and competent colleagues? If yes, this opportunity of becoming Director for Clinical Reporting in Global Data Science could be the right next step in your career!...

Are you passionate about leadership and bringing out the best in other people? Do you have an innovative mindset that drives change in a fast-changing environment? Do you like working with engaged and competent colleagues? If yes, this opportunity of becoming Director for Clinical Reporting in Global Data Science could be the right next step in your career!...

A t ALK, we are dedicated to creating solutions that improve the lives of people suffering from allergies. As Portfolio Management Lead in New Product Planning and Portfolio Strategy, you will play a crucial role in guiding the development of new products and optimizing the lifecycle management of existing treatments within Respiratory Allergy, Food...

Senior Product Standardisation Specialist Apply remote type Hybrid locations Ådalsvej 99 Hørsholm time type Full time posted on Posted 3 Days Ago job requisition id R1068191 In the VELUX Group, we offer you a world of opportunities and the chance to create a bright future. From the forefront of the sustainable indoor living industry, we enable those who...

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...

In the VELUX Group, we offer you a world of opportunities and the chance to create a bright future. From the forefront of the sustainable indoor living industry, we enable those who live, work and play under the roof transform their spaces and live a healthier everyday life with more daylight and fresh air. The VELUX Group is an international, family-owned...

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...