Regulatory Compliance Expert

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...

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 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...

Responsibilities: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:Verify and approve Standard Operating Procedures (SOPs) and ensure compliance with external...

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...

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...

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 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...

At AGC Biologics A/S, we are committed to improving patients' lives by developing and manufacturing biopharmaceuticals. Our QC Bioassay team plays a vital role in this process, ensuring the quality and reliability of our products.Key ResponsibilitiesThe successful candidate will have the following responsibilities:Review and approve analytical results from...

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 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...

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...

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...

About the RoleIn this challenging and dynamic environment, you will be responsible for supporting Supply Chain, Process Transfer, and QC for late-stage and commercial products.Your key duties will include closing collaborations with internal stakeholders, managing change control, deviations, and CAPAs, reviewing and approving material specifications, 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...

Welcome to Reckitt BenckiserWe are a global company dedicated to protecting, healing, and nurturing in the pursuit of a cleaner, healthier world. Our hygiene, health, and nutrition brands are trusted by millions worldwide.The OpportunityThis Regulatory Affairs role offers a unique chance to make a meaningful impact on our product portfolio. As a key member...

Company Overview:Novo Nordisk A/S is a leading healthcare company that focuses on developing innovative treatments for people with diabetes and other serious chronic conditions. Our vision is to make a significant difference in patients' lives by delivering high-quality products and services.We are committed to fostering a culture of innovation,...

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...

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...