Regulatory Document Specialist

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...

Job DescriptionWe are seeking a Senior Medical Writer - Regulatory Documents to join our Clinical Reporting team. The successful candidate will have a master's degree within natural sciences, preferably supplemented with a PhD and/or relevant experience in the pharmaceutical industry.Key responsibilities include:Planning, development, and oversight of...

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...

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...

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 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...

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...

Required Skills and QualificationsTo succeed in this role, you will need to have:A master's degree within natural sciences, preferably supplemented with a PhD and/or relevant experience in the pharmaceutical industryA track record of driving complex tasks from start to end, navigating a multidisciplinary stakeholders' landscapeA high level of expertise in...

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 JobWe are looking for a highly skilled and experienced Clinical Project Manager Medical Writing to join our team in Clinical Reporting. As a key member of our function, you will be responsible for driving the preparation of complex clinical documents and acting as project manager.Main ResponsibilitiesLead tasks such as planning, development, and...

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...

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 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...

Job DescriptionWe are seeking an experienced Clinical Trial Operations Manager to join our team at Novo Nordisk A/S. As a Clinical Trial Operations Manager, you will be responsible for overseeing the submission of clinical trials to regulatory authorities worldwide.The successful candidate will have extensive experience in project management, with a strong...

We are passionate about connecting the Medical & Science organization while driving scientifically sound medical deliverables across the Novo Nordisk project portfolio. As a Clinical Outcome Assessment Specialist, you will be part of this ambitious journey towards ensuring that patients' experiences, perspectives, needs, and priorities are captured and...

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...

About the RoleWe are seeking a highly skilled and experienced QA Specialist to join our team in Clinical Trials. As a member of our Quality Assurance department, you will play a crucial role in ensuring the quality and safety of products for clinical trials. In this dynamic environment, you will work closely with our team of experts to deliver best-in-class...

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...

At Novo Nordisk A/S, we are driving innovation in medical devices and drug-device combination products. We are seeking a skilled Professional to join our Regulatory Affairs (RA) Device and Digital Health department.Job Description:Develop and implement regulatory strategies for primary packaging submissions across various projects.Collaborate with...