Biologics Regulatory Expert

We are seeking a highly experienced Biologics Regulatory Specialist to join our Regulatory Affairs CMC team at Genmab A/S. As a key member of our team, you will be responsible for providing regulatory expertise and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of global...

About the RoleAt Genmab, we're pushing the boundaries of antibody therapies to transform lives. As a Director/Associate Director, Global Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy for biologics.This exciting opportunity requires a seasoned professional with expertise in CMC regulatory affairs, strategic thinking, and...

As a QC Method Validation Expert, you will play a critical role in ensuring the accuracy and reliability of our analytical methods. You will work closely with our cross-functional teams to develop and implement methods that meet regulatory requirements, participate in operational planning, and ensure all activities follow cGMP guidelines.The QC Department is...

Join Our Team:We are a global pharmaceutical company specializing in allergy immunotherapy, driven by professionalism, integrity, and an open-minded approach. Our team values skill and knowledge creation, and we provide an attractive working environment for individuals seeking personal and professional growth.About the Position:This role offers an exciting...

Lundbeck A/S is a global pharmaceutical company dedicated to transforming lives through innovative treatments for brain disorders. As a leading developer of life-changing medicines, we strive to make a meaningful difference in the lives of people affected by these conditions.As a Regulatory Expert in Pharmaceutical Quality Assurance, you will play a crucial...

Mito Consulting is committed to providing exceptional service to our clients in the BioPharma industry.Regulatory Compliance ExpertWe are seeking a highly skilled Regulatory Compliance Expert to join our team. The ideal candidate will have a strong background in regulatory compliance and quality control, with experience working in the BioPharma industry.The...

Join Black Swans Exist, a pioneer in microbiome-based therapies for women's reproductive health, as a Director of Regulatory Affairs. This pivotal role demands a visionary leader who can drive global regulatory strategies and navigate complex regulatory landscapes.About the PositionIn this high-stakes position, you will oversee the development and approval...

Black Swans Exist, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a seasoned Director of Regulatory Affairs to spearhead their global regulatory strategies.About the RoleIn this high-impact position, you will drive the development and approval of innovative biologics, combination drug-device...

We are seeking a skilled and experienced Regulatory Affairs Director to join our team at Genmab A/S. As a key member of our Regulatory Affairs CMC team, you will be responsible for providing strategic regulatory guidance and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of...

We are seeking an experienced Clinical Production Support Expert to join our Clinical Team in Manufacturing Product Support department. As a key member of our team, you will be responsible for providing technical support for clinical production, ensuring compliance with GMP regulations.The ideal candidate has experience working in a cGMP environment and is...

Get AI-powered advice on this job and more exclusive features. Senior Business Development Consultant at Black Swans Exist Director of Regulatory Affairs Are you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health,...

We are looking for a Senior Regulatory Expert to join our team at Macure Pharma. As a key member of our Regulatory Affairs department, you will be responsible for implementing and optimizing our new Submission Publishing Tool. Your expertise in eCTD publishing and regulatory submission workflows will be instrumental in shaping our digital regulatory...

We are looking for a highly skilled Global Regulatory Lead to join our Regulatory Affairs CMC team at Genmab A/S. As a key member of our team, you will be responsible for providing strategic regulatory guidance and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of global...

This is an excellent opportunity for someone who is passionate about quality and regulatory affairs to join a leading company in the medical device industry. As a QA/RA specialist, you will be responsible for ensuring compliance with regulatory requirements, including MDR and ISO 13485, and will have the opportunity to work on a wide range of projects, from...

At AGC Biologics, we strive to bring hope to life by enabling life-changing therapies for patients around the globe. Our mission is to work side-by-side with our customers to improve patients' lives by bringing new biopharmaceuticals to market.We are currently seeking a highly skilled Scientist in Quality Control to join our QC General Analytics team. As a...

Unlock the Potential of Regulatory AffairsGenmab A/S is seeking a highly experienced and skilled Global Regulatory Expert to join its team. As a key member of the Global Regulatory Affairs organization, you will play a crucial role in shaping the company's regulatory strategies and ensuring the successful execution of global submissions.About the RoleThe...

Job Description:We are looking for a Regulatory Affairs Expert for Medical Devices to join our Clinical and Regulatory team. The ideal candidate will have a strong background in regulatory affairs, with experience in medical devices. You will be responsible for ensuring that our medical devices meet the highest regulatory standards and that we comply with...

Regulatory Quality Assurance ManagerWe are seeking an experienced Regulatory Quality Assurance Manager to join our team in QC General Analytics. The successful candidate will have a strong background in regulatory affairs and experience in quality assurance, method validations, and regulatory compliance.The ideal candidate will be responsible for ensuring...

About UsAt AGC Biologics, we're committed to bringing innovative solutions to the biotechnology industry. We believe in the power of collaboration and strive to create a healthier, happier tomorrow.Job DescriptionThis is an exciting opportunity to join our dynamic team as a Proposal Manager. In this role, you'll be responsible for leading the preparation and...

We are looking for an experienced CMC Project Manager to join our Global CMC-Development team at ALK-Abelló A/S. As a Senior CMC Project Manager, you will play a key role in managing projects in different phases, including pre-clinical, clinical phase III preparations, and Life Cycle Management/optimization projects.Your responsibilities will...