Resultat af søgning: 46 ledige stillinger
...Do you want to be a part of shaping how we in Regulatory Affairs work with data integrations/migrations in the exciting context of mergers & acquisitions? If you are ready to take on the challenge, we encourage you to apply for this exciting position as Regulatory...
...Are you motivated by working with global regulatory submissions in an international environment bringing innovative treatment to patients worldwide? Do you have a flair for planning, coordinating and for navi-gating in IT platforms? Then we offer you this great opportunity...
...Are you passionate about regulatory science and driving innovative regulatory strategies to bring innovative medicines to patients? Do you have strong scientific background combined with regulatory drug development experience? Do you want to play a pivotal strategic...
...establish close partnership and interaction with other functional areas within Novo Nordisk, especially the Clinical Development and Regulatory Affairs teams, providing you with extensive insights into the entire Novo Nordisk value chain. Taking on responsibilities,...
...flexibility, and continued compliance.
Key responsibilities of this role include:
To define and actively drive implementation of regulatory strategies from facilities point of view for product launch, capacity expansion, and other strategic projects going across the...
...support CMC API Development within the raw material and CMO shipping area. You will be responsible for ensuring compliance with regulatory requirements, quality standards, and company policies.
Key responsibilities:
• Responsible for delivering best-in-class quality...
....g. medical doctors, trial managers, safety surveillance advisers, medical writers and clinical data scientists
Interact with regulatory authorities and prepare for submission
***The position will be based in either Søborg or Aalborg.***
Qualifications
The...
...Would you like to drive regulatory strategies within weight management for initial submissions to authorities on a global scale? And are you able to cut through complexity and work across multiple functions in a very dynamic environment?
If yes, join us as a...
...Experience within project management, preferably projects in production, development, or quality assurance
Knowledge of standards and regulatory requirements (GMP) within pharmaceutical products is an advantage
Professional proficiency in English
As a person, you...
...Do you want to play a key role in accelerating the development of our patient-focused products? Are you passionate about regulatory science and executing on regulatory strategies to bring innovative medicines to patients?
If so, join our dynamic and forward-looking...
...internal reviews of shipping documents and handle deviations.
• Contribute to an inspection-ready culture and ensure compliance with regulatory requirements.
• Oversee and support shipping activities for both GMP and non-GMP materials used in clinical trials.
•...
...Validation Lead, you will play a crucial role in ensuring the validated state of the system (PAS-X), maintaining compliance with regulatory requirements, and driving continuous improvement through innovative validation and qualification strategies.
Your key responsibilities...
...and implementation of these technologies.
Main stakeholders will include colleagues in the department, Quality Assurance (QA), Regulatory Affairs, and our Quality Control (QC) laboratories.
Qualifications
To succeed in this role you have:
• An academic degree...
...level of commitment. We collaborate with different stakeholders in the organization including production departments, research, regulatory affairs, and QA. We therefore enjoy being part of a wide range of activities and projects within the organization.
Our department...
...packaging materials from clinical development to market, such as receiving documentation from R&D and primary packaging related regulatory filing activities and documenting the activities to be ready for health authority inspections.
Some of your main activities include...
...across the organization
• Linking programme and redefining current scoped project, related to early and structured planning of regulatory submissions and approvals, to next level
• Driving and overseeing the cross organisational project programme with several individual...
...business. You have several years of experience working with ethics & compliance in a global setting and you understand the complex regulatory environment that a pharmaceutical company like Novo Nordisk operate in. Further you have a strong attention to detail and the...
...implementing new W&S equipment in aseptic facilities.
You have strong analytical and statistical skills.
You are well versed in regulatory requirements for W&S.
You have a high sense of quality and know how to handle Quality Management System documentation.
You...
...into our productions worldwide. Our common goal is to ensure a reliable supply of quality products (raw and packaging materials) in regulatory compliance, sustainable, and at a competitive cost to Novo Nordisk manufacturing sites globally.
You will join a dynamic team...
...securing uninterrupted supply to patients globally, at competitive costs – all without comprising quality and compliance.
Ensuring regulatory flexibility and right-level robustness in supply chains is another key responsibility of this role.
Qualifications
To...
