Biologics Regulatory Specialist

About the RoleWe're expanding our team and seeking a seasoned Regulatory Affairs Associate Director - Biologics to join our Regulatory Affairs CMC team. As a Team Lead, you will lead a sub-team while actively contributing to regulatory projects. Your experience in developing and executing CMC strategies, interacting with health authorities, and ensuring...

Lundbeck A/S, H is seeking a highly skilled Biologics Quality Assurance Specialist to join our international CMC Biologics team. As our new specialist, you will be responsible for ensuring the quality of Lundbeck's development biological drugs from Phase I to Phase III before transfer to the commercial manufacturing team.You will work closely with contract...

Job Description:As an Analytical Validation Specialist at AGC Biologics, you will be responsible for driving PhI/II and PhIII/Commercial method validation activities. You will review release and stability analytical set-ups, support lab technicians, author SOPs, and run Lab Investigations, Deviations/CAPAs, and CR cases.The ideal candidate holds a MSc or PhD...

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...

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...

Job DescriptionThe position is responsible for developing and executing global regulatory strategies for biological products during early and late stage development, and lifecycle. This includes planning, reviewing, and preparing CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages. The...

Job Description Summary LOCATION: Copenhagen, DenmarkROLE TYPE: Hybrid working (3 days per week in the office) As a member of the Regulatory Affairs (RA) team in Copenhagen, you will get the opportunity to work in a dynamic, agile team who has a common goal to bring our medicines to patients. We are looking for a Regulatory Affairs Manager or...

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 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...

About Us    AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. Our company is committed to continuous innovation, fostering technical creativity to solve clients' most complex challenges, including specialization in fast-track projects and rare...

Job DescriptionThe Senior Regulatory Affairs Specialist is responsible for ensuring regulatory compliance and securing approvals for new products, line extensions, and additional claims. They will manage the coordination and submission of regulatory applications for drugs, cosmetics, medical devices, and similar products.This role requires strong knowledge...

At AGC Biologics, we are a global 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. Our team is tailored to each client's needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation, and...

At Macure Pharma, we are seeking a seasoned Regulatory Affairs Specialist to join our team. This role offers an exciting opportunity to shape regulatory processes in a fast-growing company and play a key role in the implementation of our new Submission Publishing Tool.Key Responsibilities:Compiling, formatting and validating regulatory submissions in eCTD...

Company OverviewGenmab is an international biotechnology company committed to improving the lives of patients through innovative antibody therapeutics. With a core purpose guiding its team, Genmab has invented next-generation antibody technology platforms and leveraged translational research and data sciences.Job DescriptionWe are seeking a highly...

We're seeking a skilled expert to support clinical and commercial manufacturing for our Customers worldwide. The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or other relevant area, with +3 years of work experience in QC or analytical development. Fluency in written and spoken English is required, since English is our company...

Job RequirementsTo be successful in this role, you will need to have a deep understanding of Quality Control processes and procedures, as well as excellent communication and collaboration skills. You will also need to be able to work effectively in a fast-paced environment with changing priorities.About the RoleThis is an exciting opportunity to join a...

We are looking for a skilled CMC Biologics Technical Lead to join our team. As our new lead, you will be responsible for leading quality control activities with a focus on drug-device combination products.You will work closely with cross-functional teams, including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs. Your...

About UsC. H. Lundbeck A/S is a leading global pharmaceutical company that has been active in the production of drugs for more than 70 years. Our main goal is to develop and commercialize treatments for brain diseases. We are committed to delivering innovative treatments to patients around the world.Job DescriptionWe are seeking a highly skilled Senior...

As a Biopharmaceutical Procurement Specialist at AGC Biologics, you will play a key role in our dynamic Supply Chain team in Copenhagen. Your primary responsibility will be to source and manage indirect spend activities, ensuring the operational purchase order process is smooth and efficient. You will work closely with cross-functional partners across the...