Resultat af søgning: 316 ledige stillinger
...Exciting Senior Career Opportunity in Regulatory Affairs Combination Products!
Do you dream of a career with a global pharmaceutical company built on life-changing innovative investigational medicines and devices? Does working with highly talented and engaged...
...Senior Regulatory Scientist
We are continuing to invest in growing our Nordic business and are now seeking to hire Senior Regulatory Scientists. This role will speak to those who are excited at the pace of change and innovation in Life Science, who want have an appetite...
...expertise within scientific communication and act as an integral part of impactful agile teams?
If yes, then apply for the Senior Regulatory Content Writer position and become the newest member of our newly established Content Management Team in Clinical Reporting....
...Sr. Regulatory Publisher
(Global Regulatory Publishing, Regulatory Business Operations)
Lundbeck’s passion links to our purpose of restoring brain health so every person can be their best. We strive to make a real difference to patients. By developing innovative...
...opportunity is for you. We are looking for an experienced IT Analyst, who will support our team in implementation and enhancement of our regulatory reporting.
In Nordea, we’re harnessing the power of technology to reinvent the future of banking. Working with international...
...operation.
We offer
Maersk Air Cargo is on growth journey. Expanding into new markets at rapid pace, we are in need of a AERO regulatory affairs professional to help shape our business strategy and ensure regulatory compliance.
The Regulatory Affairs Manager in...
...for an engaged RA CMC Expert with expertise in small molecules to join RA CMC Emerging Technologies (ET) in Novo Nordisk Global Regulatory Affairs unit. If you are curious about drug development, willing to take lead, set strategic direction in projects and be a regulatory...
...more people, more effectively. The external requirements to the medical device industry are increasing and we are a Global Group Regulatory Affairs team of approx. 10 persons who facilitate and actively participate in ensuring that WSA adheres to the right standards of...
...Are you experienced within device regulatory affairs and are you passionate about finding new pathways for approval of combination products then this might be an interesting job for you
The role
Ascendis Pharmais a fast-growing, dynamic biopharmaceutical company...
..., documentation, reporting and managing project within our department.
You will work in close collaboration with development, Regulatory Affairs and manufacturing sites and you will design, interpret, and report stability studies on drug products.
We offer you a...
...closely with IT and organizational teams to identify, assess, and mitigate information security risks while ensuring compliance with regulatory requirements.
Responsibilities
As the GRC Lead, your primary responsibilities will include:
Contributing to NTG’s...
...transfer to production
Creating production documentation:
Bill of Material in ERP and PLM system
Assembly instructions
Regulatory requirements
Test descriptions
Incoming inspection instructions.
Overview of ongoing ECOs and ensuring progress...
...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...
...Review monthly expense reporting for anomalies against prior periods and budget
~Ensure compliance with applicable tax and other regulatory requirements
~Drive system implementations and optimizations as well as process improvements
~Support the team in special...
...Implementation and Configuration:
Lead the implementation and configuration of the SAP ATTP module to meet organizational and regulatory requirements.
Customize SAP ATTP solutions based on business needs and integration with existing SAP systems.
Develop and document...
...of the job.
Your main stakeholders are colleagues in the department performing the analysis, other QC departments, QA and Regulatory Affairs.
In Novo Nordisk we are on a journey of digitalizing our QC laboratories, by introducing automated processes and connecting...
...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...
...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...
...development
Ensuring seamless end-to-end processes across IT systems supporting clinical development, clinical supplies, and regulatory affairs
Testing the workflows as the system is developed and updated and take part in developing user-friendly communications...
...shortages.
Collaborate cross-functionally with stakeholders across the full value chain (commercial, manufacturing, supply chain, regulatory affairs, communication, etc.), and draw informed conclusions to address this critical issue.
Prepare and present clear...
