CMC Regulatory Specialist Expert

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...

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...

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 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...

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...

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 PositionWe are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. The successful candidate will support CMC API Development within the raw material and CMO shipping area.Your Responsibilities:Ensure compliance with regulatory requirements, quality standards, and company policies.Deliver...

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...

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...

ResponsibilitiesAs a CMC Regulatory Expertise Opportunity, you will be responsible for:Applying regulatory intelligence and establishing strategy for submission of clinical trial applications (CTAs) and marketing authorizations (MAAs)Submission of regulatory files and responding to questions from health authoritiesEnsuring the preparation, review, and...

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...

About the RoleThis position involves supporting CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.You will be responsible for delivering best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and drug product...

About the RoleIn this exciting position, you will have the opportunity to contribute to the development of new medicines and technologies that address unmet medical needs in rare diseases.Your responsibilities will include executing and driving regulatory strategies, providing expert advice on regulatory science and global development projects, and being...

About This RoleWe are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team within RA Obesity.In this role, you will be responsible for developing and executing late-stage regulatory strategies, collaborating with cross-functional teams, and overseeing regulatory submissions.Key responsibilities may include:Providing...

Are you passionate about working with data? Do you want to set directions and deliver results? Do you have the ability to handle complex tasks? If yes, we are seeking an experienced and highly motivated Regulatory Data Partner to join our team, who will be responsible for implementing and supporting our data in the Regulatory organisation, and support...

Job Description:We are looking for a Process Improvement Manager: Clinical Quality to join our team. As a GCP Advisor Specialist, you will be responsible for managing updates to our standard operating procedures (SOPs) covering the Establish Clinical Evidence process, ensuring compliance with GCP and regulatory requirements.Your Key Responsibilities:Manage...

Job DescriptionWe are looking for a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. As a member of our team, you will support CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.Your key responsibilities will...

Select how often (in days) to receive an alert: Create Alert Regulatory Affairs Specialist, RA Obesity Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Are you passionate about regulatory science and driving innovative regulatory strategies to bring innovative medicines to patients? Do you have strong...