Synthetic Small Molecules Regulatory Specialist

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 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...

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...

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 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...

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 UsWe strive to be the best in the industry, delivering safe and innovative products to patients by strategic business partnering, proactive collaboration with health authorities and efficient operations.Our organization is dynamic and there is focus on improving work processes both in relation to implementation of new regulations and thinking 'out of...

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...

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 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 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...

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 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...

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...

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...

At Novo Nordisk, we are committed to creating innovative solutions to improve the lives of patients worldwide.Company OverviewWe strive to be a leader in our industry by pushing boundaries, embracing new technologies, and fostering a culture of collaboration and innovation.The Regulatory Affairs Business Development team is responsible for evaluating...