CMC Regulatory Expertise Opportunity

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 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...

Key ResponsibilitiesApplying regulatory intelligence and establishing strategy for submission of clinical trial applications (CTAs) and marketing authorisations (MAAs)Submission of regulatory files and responding to questions from health authoritiesEnsuring the preparation, review and submission of pre-meeting packages for health authority meetings as well...

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...

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...

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...

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...

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...

Select how often (in days) to receive an alert: Create AlertRegulatory Affairs Business Development DirectorCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKDo you have experience developing medicinal products and identifying regulatory risks and opportunities? Are you knowledgeable about the drug development...

Select how often (in days) to receive an alert: Create Alert Regulatory Affairs Business Development Director Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Do you have experience developing medicinal products and identifying regulatory risks and opportunities? Are you knowledgeable about the drug...

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...

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...

About the Role:We are seeking a highly skilled Regulatory Affairs Business Development Director to join our team at Novo Nordisk A/S. As a member of our Regulatory Affairs Diabetes and Obesity team, you will play a pivotal role in creating global regulatory strategies to advance projects from the early stages of development to worldwide submissions and...

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Business Development Director to join our team in Søborg, Denmark.Your primary responsibility will be to lead RA BD activities and establish a Matrix Team covering all relevant regulatory skill areas. You will evaluate external assets and companies for in-licensing, partnerships, or...

We are seeking a highly skilled Professional to join our Regulatory Affairs (RA) Device and Digital Health department at Novo Nordisk A/S. The ideal candidate will have a strong background in regulatory affairs, with expertise in primary packaging development and submission planning.About the Role:This role offers a multi-disciplinary environment with...