Regulatory Affairs Leader for Biologics and Rare Diseases

Job Description:We are seeking an experienced leader to join our team as the Director of Regulatory Affairs for CMC Biologics and Rare Diseases. As a key member of our leadership team, you will play a pivotal role in shaping the future of RA CMC. Your expertise in drug regulatory affairs will drive excellence in our pipeline and deliver regulatory approvals...

Director of Regulatory Affairs for CMC Biologics & Rare Diseases Category: Project Management & Agile Location: Søborg, Capital Region of Denmark, DK Are you an experienced purpose-driven and business-minded second line leader with extensive expertise in drug regulatory affairs? Do you excel in a dynamic environment and want to be part of a rapidly...

Job Summary:The Director of Regulatory Affairs for CMC Biologics will be responsible for developing and executing regulatory strategies for biologics and rare diseases. This role requires a highly experienced and visionary leader who can inspire and empower teams to deliver high-quality results.Key Challenges:Developing and executing global approval...

About Novo Nordisk:Novo Nordisk A/S is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Our success relies on the joint potential and collaboration of our more than 69,000 employees around the world. We recognize the importance of unique skills and perspectives our people bring to the table.Key...

Job Overview:We are seeking a highly experienced and visionary leader to spearhead our team as the Director of Regulatory Affairs for CMC Biologics and Rare Diseases. This role requires a dynamic and ambitious individual with a strong track record of driving change and innovation in regulatory affairs.Key Requirements:A Master of Science degree in natural...

Job DescriptionSafety Surveillance Rare Disease is a team within Global Safety at Novo Nordisk, responsible for the establishment of product safety profiles during clinical development and analysis of emerging aggregate safety data. The team handles projects related to rare disease indications from development to post-marketing.About the RoleThis position...

About the RoleThe position of Global Director for Health Economics & Outcomes Research (HEOR) at Novo Nordisk A/S is a crucial role in shaping the company's approach to rare disease treatment access worldwide.As a seasoned expert in Health Economics and Outcomes Research, you will lead the development of strategies, plans, and tactics within the HEOR domain....

About the TeamThe Rare Blood Disorders Market Access and Pricing team is a dedicated group of professionals working to support best global access of our assets that help people with Haemophilia, sickle cell disease (SCD), and Thalassemia. This requires cross-function collaboration, innovation, and senior leadership interaction.As the Global Director for...

Job SummaryThis is an exceptional opportunity to make a meaningful impact in the realm of rare disease treatment access. As the Global Director for Health Economics & Outcomes Research, you will be at the forefront of pioneering initiatives that shape the way rare disease treatments are perceived, valued, and accessed worldwide.Key responsibilities...

About the PositionThis is an exciting opportunity for a highly motivated and experienced professional to lead our Health Economics and Outcomes Research (HEOR) function globally. As the Global Director for Health Economics & Outcomes Research, you will be responsible for developing and implementing strategies, plans, and tactics within the HEOR domain,...

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.At AGC Biologics, you will get a unique opportunity working with a variety of state-of-the-art technologies among +40 different nationalities.This opens many doors for personal development and for...

JobbeskrivelsePlacering Søborg, DenmarkJobkategori Market Access Ansøg nu Are you ready to make a meaningful impact in the realm of rare disease treatment access? As the Global Director for Health Economics & Outcomes Research, you will be at the forefront of pioneering initiatives that shape the way rare disease treatments are perceived, valued, and...

Jobbeskrivelse Placering Søborg, Denmark Jobkategori Market Access Ansøg nu Are you ready to make a meaningful impact in the realm of rare disease treatment access? As the Global Director for Health Economics & Outcomes Research, you will be at the forefront of pioneering initiatives that shape the way rare disease treatments are perceived, valued, and...

About the RoleWe are seeking a Senior Clinical Strategist to join our team in Copenhagen, Denmark. As a key member of our clinical drug development team, you will be responsible for developing and executing clinical strategies for our pipeline, collaborating with cross-functional teams, and ensuring timely delivery of projects.Your ResponsibilitiesDesign and...

We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest...

Job SummaryWe are looking for a highly motivated and detail-oriented Compliance Engineer to join our team. As a Compliance Engineer, you will play a key role in ensuring that our facilities and processes meet regulatory requirements.About the PositionYou will be part of the Plant Engineering department, responsible for implementing and maintaining quality...

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way.We provide world-class development and manufacture of mammalian and microbial-based therapeutic...

About the RoleThe Global Director for Health Economics & Outcomes Research will be at the forefront of pioneering initiatives that shape the way rare disease treatments are perceived, valued, and accessed worldwide.This role entails leading the development of health economic models, collaborating with multiple stakeholders, and working closely with the...

At AGC Biologics, our purpose is to bring hope to life by enabling life-changing therapies for patients worldwide. We create a healthier and happier tomorrow by working side by side with our customers to improve patients' lives through new biopharmaceuticals.We are seeking an experienced QA scientist to assist with Quality Assurance of Material Management....

Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Job Description - Senior Regulatory Affairs Specialist (2507030367W) Who we are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands —...