Submission Expert Lead

Role OverviewWe are seeking an experienced Regulatory Affairs Specialist to join our Device and Digital Health team at Novo Nordisk A/S. In this role, you will be responsible for driving submission activities related to primary packaging and collaborating with colleagues across the organization.Main ResponsibilitiesThe main responsibilities of this role...

Category: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKAre you passionate about clinical trial submissions? Do you possess a talent for overseeing project management and ensuring compliance with global requirements? If so, we have an exciting opportunity for you to join our newly established team of Submission Managers...

At Novo Nordisk A/S, we are seeking a highly skilled Regulatory Affairs Professional to join our team. This role will play a key connection between scientists and Health Authority regulators, ensuring fast and successful regulatory submissions and approvals in all global markets.About the RoleThis is an exciting opportunity for a talented individual to join...

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...

Key ResponsibilitiesAs a Regulatory Affairs Professional, you will be responsible for:Planning, coordinating and executing regulatory submissions.Creating, planning and coordinating submission timelines in collaboration with CMC subject matter experts (SME), affiliates and other key stakeholders.Defining and driving needed updates of the Quality (M3) drug...

About the RoleWe are seeking an experienced Automation Expert Lead to oversee resource responsibility for AP Automation standardization. This includes providing input for procurement and handling technical clarifications before and during execution, preparing and participating in FAT, SAT and commissioning.Main ResponsibilitiesResource Responsibility:...

About the TeamRA Obesity is a new and expanding area within Global Regulatory Affairs consisting of 20 dedicated and highly engaged Global Regulatory Leads, Regulatory Specialists, and Professionals, organised in two teams.We are responsible for developing and executing on global regulatory strategies, designed to advance projects across multiple...

Novo Nordisk A/S: Global OpportunitiesWe're a dynamic and innovative company with a strong commitment to making a positive impact on people's lives. Our team members enjoy diverse career paths, opportunities for growth, and a supportive work environment that fosters collaboration and creativity.Job DescriptionWe're seeking an experienced Global Clinical...

Job DescriptionAs a Regulatory Affairs Professional, you will play a key role in ensuring fast and successful regulatory submissions and approvals in all global markets. You will join an experienced team working with oral products, focusing on RA CMC life-cycle management activities.Your main responsibilities will include:Planning, coordinating, and...

We are seeking a highly experienced Medical Director to lead our global clinical development efforts in obesity. As a key member of our team, you will be responsible for driving the planning and design of clinical studies and providing medical oversight during study conduct.Key ResponsibilitiesLead cross-functional teams to develop and implement clinical...

We are Reckitt, a global team united by our purpose of protecting, healing and nurturing in the relentless pursuit of a cleaner, healthier world.Our Finance team is not just another department; we're strategic partners and catalysts for change, who use our expertise to drive sustainable growth and create value for Reckitt.About the RoleAs a member of the...

Job SummaryWe are seeking an experienced Regulatory Affairs Specialist to join our Device and Digital Health team at Novo Nordisk A/S. In this role, you will be responsible for driving submission activities related to primary packaging and collaborating with colleagues across the organization.About the RoleThe ideal candidate will have substantial global...

We are looking for a Senior Medical Lead to join our Obesity Clinical Development team. In this role, you will be responsible for leading the development of clinical trial protocols, coordinating with investigators and site personnel, and ensuring the integrity of our clinical trials.ResponsibilitiesDevelop and execute clinical trial plans, including...

About Our TeamIn Development, we manage clinical drug development worldwide. We provide medical and scientific documentation for clinical submissions while ensuring global standards, regulations, and business ethics.The Department of Real World Evidence focuses on rapid data insights using descriptive methods and causal relationships from real-world data. We...

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Professional to join our RA CMC & Device team. As a key member of our organization, you will play a crucial role in ensuring the success of Novo Nordisk's expanding product portfolio.About the RolePlan, coordinate and execute regulatory submissions.Create, plan and coordinate submission...

About Novo NordiskWe're a dynamic company in the biopharmaceutical industry, dedicated to driving innovation and making a meaningful impact on patient care.Our commitment to excellence is evident in our research and development efforts, where we strive to move the needle on therapeutic areas like obesity.The RoleWe're seeking a skilled Regulatory Affairs...

The Regulatory Affairs Diabetes and Obesity therapeutic area is a key player in creating global regulatory strategies to advance projects from the early stages of development to worldwide submissions and approvals of initial Marketing Authorisation applications. As a senior member of this team, you will have the opportunity to collaborate with...

About the Role\This exciting opportunity is part of Novo Nordisk's Global Regulatory Affairs team. As a Regulatory Specialist, you will play a key role in shaping the company's regulatory strategies and ensuring compliance with regulatory requirements.\Key Responsibilities:\\Develop and implement effective regulatory strategies to support the development and...

Company OverviewNovo Nordisk A/S is a dynamic and innovative company dedicated to delivering life-changing care for people living with chronic conditions. As part of our team, you will be instrumental in ensuring the smooth operation of clinical trials, driving compliance, and pushing the boundaries of what is possible.Job DescriptionWe are seeking an...

Key ResponsibilitiesThe Senior Global HEOR Manager will be responsible for the following key responsibilities:Developing and implementing HEOR strategies and tools to support market access preparedness for our RRED productsSetting evidence generation plans and collaborating with cross-functional teamsMaintaining relationships with key external...