Regulatory Chemistry Manufacturing and Control Expert

QualificationsA Master and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health authority.A minimum of 8+ years of experience with synthetic small molecules experience is preferred, as well as experience in the following areas:In-depth knowledge of regulatory CMC requirements for clinical...

Key ResponsibilitiesYour main objectives as a Senior QP delegate in our CMC API QA team will be to ensure that all API released for clinical trials meet the highest quality standards, participate in regulatory inspections and audits, and ensure compliance with cGMP and other regulatory requirements. Additionally, you will work closely with colleagues to...

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...

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...

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...

Select how often (in days) to receive an alert: Create AlertExpert in Regulatory Affairs - Primary PackagingCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKAre you ready to take on new challenges in primary packaging development across emerging therapeutic areas and innovative products? Would you like to use...

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...

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...

Are you passionate about shaping the future of your area? Do you want to contribute to the development and scaling of our Complaints, Inspections & Audit processes?We are seeking a highly skilled and experienced Senior QA Professional to join our team at Novo Nordisk A/S. The ideal candidate will have a strong background in quality assurance, regulatory...

About UsNovo Nordisk A/S is a global healthcare company with a strong commitment to improving the quality of life for people around the world. Our mission is to make a meaningful difference in the lives of people affected by chronic and rare diseases.The TeamYou will become part of a great department with many interfaces around the organisation, both in...

As an Upstream Process Transfer Scientist at AGC Biologics, you will be responsible for the transfer of upstream processes from development to manufacturing.This role requires collaboration with cross-functional teams, leadership of technology transfer activities, and provision of technical expertise in upstream bioprocessing.Key responsibilities include...

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...

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...

Company OverviewNovo Nordisk A/S is a dynamic company that drives change in the pharmaceutical industry. We strive for excellence without fixating on perfection and seize opportunities to develop.We are responsible for Quality Assurance of Novo Nordisk's local manufacturing CMOs; we currently consist of eight QA colleagues working closely together, covering...

About the RoleIn this dynamic team, you will work closely with other QA specialists to ensure that our production processes meet the highest standards of quality and compliance. You will be responsible for setting the quality direction for the capacity expansion project, delivering best-in-class quality for qualification of equipment/facilities and...

Ferrosan Medical Devices A/S is a leading manufacturer of medical devices used in surgical care. Our products are designed to minimize bleeding challenges in surgery and electromechanical medical devices for performing breast biopsies. We're committed to improving patient outcomes and take our values to work every day – we care about each other, our...

Hygiene Compliance ExpertWe are seeking an experienced Regulatory Affairs professional to join our Hygiene division. This role involves ensuring compliance with complex regulatory frameworks and driving product innovation in the Nordic market.Your Main ResponsibilitiesDevelop and implement effective regulatory strategies to support product launches.Maintain...