Current jobs related to Regulatory Affairs Professional - Gladsaxe, Gladsaxe Municipality - Novo Nordisk AS
-
Regulatory Affairs Professional
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create AlertCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKDo you want to be part of a growing organization, contributing to the success of Novo Nordisk's expanding product portfolio? Are you passionate about regulatory guidelines and committed to ensuring...
-
Regulatory Affairs Expert
18 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAt 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...
-
Regulatory Affairs and Clinical Trials
1 week ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeWe are recruiting for a Regulatory Affairs and Clinical Trials professional to join our team at Novo Nordisk A/S. As a Global Trial Manager, you will play a critical role in ensuring the quality and integrity of our clinical trials.Key responsibilities include:Ensuring compliance with regulatory requirements, good clinical practices, and internal...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the Role">This position offers the chance to work on exciting projects and contribute to Business Development (BD) activities across Novo Nordisk's therapeutic areas, representing Global Regulatory Affairs within the Global Project BD Team.">You will be responsible for leading Regulatory BD activities and establishing a Matrix Team covering all...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the Department">The RA Obesity department at Novo Nordisk A/S is a rapidly expanding area within Global Regulatory Affairs. This department is responsible for developing and executing on global regulatory strategies that advance projects across multiple indications from early stages of development through to worldwide submission and approval of initial...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout 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...
-
Regulatory Affairs Strategist
1 week ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to develop and execute the late-stage regulatory strategy for a key project. This role requires strong scientific knowledge and regulatory expertise to evaluate strategies, manage multiple regulatory tasks with overlapping timelines, and collaborate closely with Global Regulatory...
-
Pharmaceutical Regulatory Professional
10 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeNovo Nordisk A/S is seeking a highly skilled Regulatory Affairs Professional to join our team. In this role, you will play a key role in ensuring the success of our regulatory submissions and approvals. You will work closely with scientists and Health Authority regulators to ensure the smooth execution of regulatory activities, focusing on the creation,...
-
Expert in Regulatory Affairs
3 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect 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...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob Overview">We are seeking a highly skilled and experienced Regulatory Affairs professional to join our team as a Regulatory Affairs Strategic Development Director. In this role, you will be responsible for leading the development and implementation of regulatory strategies to support the commercialization of medicinal products.The ideal candidate will...
-
Regulatory Affairs Transformation Leader
1 week ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout UsWe are committed to securing process excellence and digital innovation to reach more patients faster by simplifying and standardizing ways of working with a focus on end users. Our Regulatory Affairs team manages submission, registration, and labelling to obtain authority approval for all Novo Nordisk products. We work across the value chain from...
-
Nordic Regulatory Affairs Expert
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Reckitt Benckiser Full timeNavigating Complex Regulations to Drive Business SuccessIn this dynamic role, you will leverage your expertise in regulatory affairs to drive business growth and expansion while ensuring compliance with product safety standards and regulatory requirements in Nordic markets. As a Regulatory Affairs Associate in our Hygiene division, you will develop and...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the Department">The Regulatory Affairs Diabetes and Obesity therapeutic area is responsible for 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 key member of this team, you will collaborate with cross-functional...
-
Regulatory Affairs Process Strategist
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout UsWe are a global pharmaceutical company committed to creating innovative solutions for better lives.Our Regulatory Affairs team plays a crucial role in ensuring the safe and effective use of our products.Job DescriptionKey Responsibilities:Develop and implement process strategies to drive excellence in regulatory affairsManage cross-functional...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob Description\Novo Nordisk A/S is seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs and be able to drive the strategic direction of innovative development projects.\Main Responsibilities:\\Execute and drive the regulatory strategy to obtain approvals\Provide...
-
Global Regulatory Affairs Lead
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeThe 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...
-
Regulatory Affairs Business Development Director
3 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect 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...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect 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...
-
Regulatory Affairs Specialist
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeCompany OverviewNovo Nordisk A/S is a dynamic company in the pharmaceutical industry, driven by innovation and a commitment to patient care. We strive for excellence without fixating on perfection, embracing experimentation and seizing opportunities for growth.Job DescriptionWe are seeking an experienced Regulatory Affairs Specialist to join our Device and...
-
Biologics Regulatory Affairs Expert
1 week ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeGlobal Regulatory CMC Leadership RoleAbout Our CultureWe recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.About the JobWe are seeking a highly...
Regulatory Affairs Professional
2 weeks ago
Select how often (in days) to receive an alert: Create Alert
Category: Reg Affairs & Safety Pharmacovigilance
Location:
Søborg, Capital Region of Denmark, DK
Do you want to be part of a growing organization, contributing to the success of Novo Nordisk's expanding product portfolio? Are you passionate about regulatory guidelines and committed to ensuring high-quality submissions? Do you thrive in a diverse, collaborative environment where teamwork and structure drive success? Then you might be our new Regulatory Affairs (RA) Professional in RA CMC & Device, handling RA CMC activities for our marketed Oral Products at Novo Nordisk.
Apply today and join us on this exciting journey for a life-changing career
The Position
As a Regulatory Affairs professional, you provide the key connection between scientists and Health Authority regulators, hence playing a key role in making medicines available to patients around the world by ensuring fast and successful regulatory submissions and approvals in all global markets. You will join an experienced, very knowledgeable, lively and friendly hybrid collaborating team with everyone working with an Oral product. The team is focused on RA CMC life-cycle management activities, and you would be joining a RA CMC product group working out of Soeborg, Denmark and Bangalore, India.
Your main responsibilities will include:
- Plan, coordinate and execute regulatory submissions.
- Create, plan and coordinate submission timelines in collaboration with CMC subject matter experts (SME), affiliates and other key stakeholders.
- Define and drive needed updates of the Quality (M3) drug product documentation package needed for a submission, including review & approve the M3 documentation, support preparation of regional documentation, drive QnA rounds in close collaboration with SMEs, and (when applicable) drive creation of the CMC part of Health Authority meeting packages.
- Identify as well as improve RA CMC practices, processes, and approaches related to RA CMC documentation and strategies.
Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office and on-site work.
Qualifications
To succeed in this role, you should have:
- A Master's degree and/or PhD in a relevant field
- At least 3-4 years of experience within the pharmaceutical industry, preferably in areas such as manufacturing, product supply, process development, CMC development, analytics, or quality assurance
- Strong communication skills, as collaboration in multidisciplinary project teams is essential
- A proactive, positive, and professional approach to challenges
- Enjoy working in diverse teams with colleagues from various backgrounds
- High proficiency in English - written as well as spoken
You are a dedicated team player; you find it easy to build working relationships and gain recognition amongst stakeholders with your proactiveness and integrity. Furthermore, you thrive in the challenging reality of international communication across time zones and cultures.
About the Area and Department
RA CMC & Device consists of four areas with two working specifically with RA CMC. We are skilled, collaborative, friendly, and dedicated colleagues with diverse backgrounds and experience, and you will be part of a dynamic and committed organization handling many projects in different phases of development. Also, as Novo Nordisk's product portfolio grows, the RA CMC & Device organization is also looking into developing innovative solutions to increasingly complex CMC manufacturing strategies and regulatory requirements.
There is a high focus on individualized onboarding, flexibility, empowerment, and individual development in the area. Well-being and psychological safety are also a major focus and are considered essential for the working environment. We strive for a modern way of working, including friendly colleagues, camaraderie, and space to be proactive, to learn, and to take the initiative to improve and make a difference. We want it to be the best place to work – not only in words, but we walk the talk in this area.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we are all working to move the needle on patient care.
Contact
For more information regarding the role, you are welcome to contact Michala Ebba Victor on
Deadline
13 April 2025.
If you are interested in this role, please apply as soon as possible. Applications will be evaluated on an ongoing basis.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
#J-18808-Ljbffr