Regulatory Chemistry Manufacturing Control Strategist

Job DescriptionThis role offers a unique opportunity to join a dynamic team in a fast-paced, global environment. As a CMC Regulatory Specialist, you will play a critical role in ensuring the successful development and approval of our synthetic small molecule projects. Your expertise in regulatory affairs, combined with your knowledge of synthetic small...

About the RoleWe are seeking an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist to join our Synthetics & Cell Technologies Department in the RA CMC Biotech & Rare Disease area within Novo Nordisk.The successful candidate will provide strategic, tactical, and operational regulatory input to projects, leading activities...

The Ideal CandidateWe are looking for an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join our team. The ideal candidate will have a Master's and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health...

About the RoleWe are seeking an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join our team. As a key member of our regulatory affairs department, you will provide strategic, tactical, and operational regulatory input to projects. Your responsibilities will include...

Our purpose is to bring hope to life by enabling life-changing therapies for patients worldwide.We are seeking a motivated Senior Scientist, Quality Control to lead and participate in coordination and planning of analytical QC activities and support clinical and commercial manufacturing for our Customers globally.The RoleDrive PhI/II and PhIII/Commercial...

Job OverviewThe QC Raw Material team at AGC Biologics is seeking a highly skilled Senior/Principal Scientist to support the implementation of new raw materials for phase I/II projects and planning the Raw Material Qualification and Release Testing program for late-stage projects.Main ResponsibilitiesDevelop and review raw material specifications based on...

Select how often (in days) to receive an alert: Create AlertCategory: Reg Affairs & Safety PharmacovigilanceLocation: Søborg, Capital Region of Denmark, DKWe 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...

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...

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 planning...

Job OverviewWe are seeking an experienced CMC Regulatory Specialist to join our team in Novo Nordisk A/S. As a key member of our regulatory affairs department, you will be responsible for providing strategic, tactical, and operational regulatory input to projects.The ideal candidate will have expertise in synthetic small molecules and experience working with...

About the RoleThis is an exciting opportunity for a motivated and experienced Regulatory Affairs Chemistry Specialist to join our team at Novo Nordisk A/S. As a CMC Regulatory Specialist, you will provide expert advice on regulatory requirements for clinical trial applications (CTAs) and marketing authorizations (MAAs).You will be responsible for ensuring...

Join a dynamic and international company where everyone is responsible for delivering right on time as one team The Position By joining the QC Raw Material team, you will be key in implementing new raw materials to support new phase I/II projects as well as planning the Raw Material Qualification and Release Testing program for late stage projects. As part...

About Novo Nordisk A/SWe are a dynamic company in an even more dynamic industry, always striving to drive change and move the needle on patient care.Our team is responsible for developing and executing global regulatory strategies, advancing projects across multiple indications from early development through worldwide submission and approval.As a Global...

About AGC BiologicsWe are a leading biopharmaceutical company dedicated to bringing new therapies to market through collaboration with our Customers.The JobCoordinate and plan analytical QC activities, drive method validation activities, and review release and stability analytical set-ups.Support lab technicians, author SOPs, run Lab Investigations,...

About the CompanyWe are Reckitt Benckiser, a global leader in hygiene, health, and nutrition. Our purpose is to protect, heal, and nurture in the pursuit of a cleaner, healthier world.The RoleAs a Regulatory Affairs Associate within our Hygiene division, you will be at the forefront of innovation and compliance efforts. You will work closely with a dynamic...

Company OverviewNovo Nordisk A/S is a leading global healthcare company that discovers, develops, produces and markets medicines for human use.Job DescriptionIn this role, you will join the API Manufacturing Development team, working at the interface between R&D and full-scale manufacturing with a focus on process understanding, implementation and...

City: Soborg We are Reckitt Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and...

Key Skills and QualificationsTo succeed as an Upstream Process Transfer Scientist, you should possess:A PhD or M.Sc. in biochemistry, protein chemistry, biotechnology, or a related field.Experience within process development and/or manufacturing within upstream processing.A flexible approach and desire to take on new tasks and responsibilities.Proven...

At Novo Nordisk, we are committed to creating innovative solutions to improve the lives of patients worldwide.Company OverviewWe strive to be a leader in our industry by pushing boundaries, embracing new technologies, and fostering a culture of collaboration and innovation.The Regulatory Affairs Business Development team is responsible for evaluating...

About AGC Biologics:We are 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. Our purpose is to bring hope to life by enabling life-changing therapies for patients...