Regulatory CMC Expert

About the RoleAs a CMC Regulatory Specialist at Novo Nordisk, you will provide strategic, tactical, and operational regulatory input to projects. You will lead activities for synthetic small molecule projects in late development as well as drive scientific and regulatory discussions across our portfolio.In this role, you will work closely with stakeholders...

Strategic Regulatory Planning RoleWe are seeking an experienced Strategic Regulatory Planning Specialist to join our Regulatory Affairs (RA) CMC & Device team in Denmark. This pivotal role is instrumental in driving governance for the prioritization of regulatory plans, ensuring strategic long-term planning, partnering with stakeholders, and driving...

About Novo Nordisk A/SNovo Nordisk A/S is a leading global healthcare company with a strong focus on diabetes and obesity. Our mission is to drive change to defeat life-threatening diseases.Our Regulatory Affairs (RA) team plays a critical role in ensuring that our products meet the highest regulatory standards.This pivotal role is instrumental in driving...

Role Summary:We are seeking a highly skilled Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist to join our team at Novo Nordisk A/S.In this role, you will be responsible for providing strategic regulatory input to projects, including developing regulatory strategies for submission of clinical trial applications (CTAs) and marketing...

As a key member of our Health team, you will play a critical role in ensuring compliance with regulatory requirements and driving innovation in our product portfolio.About the RoleThis is a fantastic opportunity to develop your skills and expertise in regulatory affairs, working closely with cross-functional teams to achieve our business...

About ReckittWe are a global team united by our purpose to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are home to the world's best loved and trusted hygiene, health, and nutrition brands.The RoleAs a Compliance Specialist in our Regulatory Affairs department, you will be responsible for ensuring on-going regulatory...

About the JobThis is an exciting opportunity to join our team as a CMC Regulatory Specialist and contribute to the development of new medicines at Novo Nordisk. As a member of our team, you will work closely with stakeholders across multiple functions in a global environment to ensure compliance with regulatory requirements.You will be responsible for...

Quality Assurance Professional OpportunityWe are seeking a highly motivated and experienced Quality Assurance Professional to join our Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA team.The successful candidate will support CMC API Development within the raw material and CMO shipping area. You will be responsible for...

Job DescriptionThe role of a Quality Specialist with expertise in In-Vitro Diagnostics Regulations (IVDR) is crucial in driving the direction for quality standards in diagnostics at Novo Nordisk A/S. As a key member of the RDQ Operational Excellence department, you will be responsible for ensuring compliance with IVD regulations and other relevant...

About the RoleWe are looking for a highly skilled GMP Training and Compliance Expert to join our QMS & Training team in the Quality Systems department. In this role, you will play a key part in maintaining and developing our Quality Management Systems, ensuring compliance with regulatory requirements and industry standards.As a GMP Training and Compliance...

About the RoleWe are seeking a highly experienced and motivated Principal Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S.The successful candidate will serve as QP delegate, primarily responsible for releasing internal and externally produced Active Pharmaceutical Ingredients (API) for usage in clinical trials. Key...

At AGC Biologics, we strive to bring hope to life by enabling therapies for patients worldwide.About the RoleThis is a leadership position that involves guiding a team of dedicated QC HPLC Scientists in method validations, analytical data generation, and customer interactions.The successful candidate will lead a unit of 10 skilled scientists working closely...

About Novo Nordisk A/S">We strive for excellence in all our endeavors, consistently pushing the boundaries of innovation to improve the quality of life for patients worldwide. As a global leader in diabetes care and biopharmaceuticals, we understand the importance of quality in every aspect of our operations.">The Role">As a Quality Assurance Expert for...

Our purpose at AGC Biologics is to bring hope to life by enabling life-changing therapies for patients worldwide, creating a healthier and happier tomorrow.Company OverviewAGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering exceptional service as we collaborate...

Are you passionate about ensuring data accuracy and integrity? Do you want to make a real impact in the pharmaceutical industry?We are seeking an experienced Senior Master Data Quality Professional to join our Global Patient Safety and Regulatory Affairs Quality team at Novo Nordisk A/S.About the RoleThe successful candidate will be responsible for ensuring...

Job DescriptionThe role of Quality Specialist with expertise within In-Vitro Diagnostics is a key position in the RDQ Operational Excellence department at Novo Nordisk A/S.Key ResponsibilitiesEnsure compliance with IVD regulations and other relevant requirements.Act as a Quality Partner and support key projects with IVD solutions.Collaborate with...

Job Description">We are seeking an experienced leader to manage our insulin safety team, which plays a critical role in ensuring the safe use of our products by patients worldwide.Your Key Responsibilities">">Lead a team of safety surveillance experts to advance pharmacovigilance and safety surveillance activities, ensuring compliance with regulatory...

About Us">At AGC Biologics, we're driven by a shared purpose: to bring hope to life by enabling life-changing therapies for patients worldwide. As a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), we work side-by-side with our clients and partners to deliver world-class development and manufacture of mammalian and...

Select how often (in days) to receive an alert: Create Alert Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK We are expanding our product and project pipeline in Novo Nordisk and are looking for an engaged Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic...

Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials and thereby secure and support the development pipeline in Novo...

Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? If so, this position as QA Professional in Chemistry,...

Select how often (in days) to receive an alert: Create Alert GMP Material Scientist for Raw Material qualification Category: Manufacturing Location: Søborg, Capital Region of Denmark, DK Are you ready for a career in the pharmaceutical industry and join a growing area taking part in the development of the future Novo Nordisk product pipeline? Are you...

Jobbeskrivelse Placering Søborg, Denmark Jobkategori Manufacturing Ansøg nu Are you ready for a career in the pharmaceutical industry and join a growing area taking part in the development of the future Novo Nordisk product pipeline? Are you looking for an opportunity to apply and develop your skills within raw materials for GMP production, process,...

Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Digital & IT Do you want to be part of our ambitious journey to digitise and automate the processes in our API Pilot factories, where the insulin and GLP-1’s of the future are being developed? Are you motivated to lead the design, implementation, and management of IT/OT solutions to enhance...

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. Experienced People Manager for QC Chemistry HPLC Scientists, Quality...

Are you an experienced Medical Writer looking to grow your career? If yes, then we would love to hear from you. The position As Medical Writing Specialist, your main responsibility is to drive the preparation of complex clinical documents and act as project manager. More specifically, you are expected to lead tasks such as: Planning, development and...

Are you a medical doctor with experience and passion for clinical drug development and at the same time keen on designing and executing clinical trial programs? Are you committed to making a difference for patients with new and innovative treatments? Then, this is your chance to be part of a team of talented medical doctors in a great and inspiring working...

Select how often (in days) to receive an alert: Create Alert International Medical Director - Obesity Category: Clinical Development Location: Søborg, Capital Region of Denmark, DK Are you a medical doctor with extensive experience in clinical drug development and are you committed to making a difference for patients with new and innovative treatments? If...

Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Supply Chain Ansøg nu Do you want to take part in the implementation of new primary packaging for Novo Nordisk and play a key role in its maintenance? Are you ready to take on the challenge of setting the direction in the challenging field of materials for use in Good Manufacturing Production (GMP)...

Jobbeskrivelse Placering Søborg, Denmark Jobkategori Clinical Development Ansøg nu Are you passionate about finding new solutions for rare Hemato-renal diseases? Do you possess extensive experience in clinical development and a deep understanding of how immunology impacts these conditions? If so, we are looking for an International Medical Director...

Are you ready for a new beginning? We need your talent, knowledge and dedication to better our world with biology. Our purpose points the way In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago, this has been our guide. It’s how we've gotten so far. And it’s how...

Select how often (in days) to receive an alert: Create Alert Do you want to be a part of the diabetes therapeutic area leading a high-performing team? Are you passionate about leadership and engaging in cross portfolio and departmental development and leadership activities? Join us and you will be working with highly talented colleagues, every one of whom...

The Company Brenntag is the global market leader in chemical and specialty ingredients distribution and has a central role in the chemical industry´s value chain. Brenntag turns 150 years this year and has activities in 78 countries with more than 700 locations. With a revenue of 16.8 billion Euros, the company employs more than 17,500 people worldwide and...

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 motivated by leading and participating in coordination and...

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 motivated by leading and participating in coordination and...

Are you passionate about innovative Clinical Drug Development with a keen eye for Haemoglobinopathies? Would you drive change for patients with Rare Diseases and relish the chance to be medically responsible for the clinical development strategy for a clinical-stage asset for patients with Sickle Cell Disease or Thalassemia? With limitless opportunities for...

Jobbeskrivelse Placering Søborg, Denmark Jobkategori Clinical Development Are you passionate about innovative Clinical Drug Development with a keen eye for Haemoglobinopathies? Would you drive change for patients with Rare Diseases and relish the chance to be medically responsible for the clinical development strategy for a clinical-stage asset for...

Would you like to drive initiatives that innovate compliance procedures through digitalization and process improvement within the pharmaceutical industry? Do you want to be at the forefront of ensuring quality and compliance in handling clinical & research data and enhancing operational efficiency in a truly global organization? If so, then you might be the...