...ikoniske brands indenfor konfekture deklareres og mærkes korrekt? Så er denne stilling måske noget for dig:
Velkommen til Quality & Regulatory
Den regulatoriske verden udvikler og ændrer sig konstant, og vi har brug for en ny kollega til vores regulatoriske team. I det...
TOMS GRUPPEN A/S
2750 Ballerup
Indrykket for 8 dage siden
...also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability...
...hospitals and care homes to provide efficient, stress-free patient care.
We are seeking a highly motivated and detail-oriented Regulatory and Compliance Specialist to join our team in Copenhagen. This role is critical in ensuring that our AI products and services comply...
...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...
...relevant expert consultants.
~Act as a scientific expert and lead interactions with external and international stakeholders (e.g. regulatory authorities, non-clinical experts/consultants, academic groups, CROs) and internal stakeholders (e.g. research, safety,...
...product portfolio and life cycle management activities in
Novo Nordisk? Would you like to be part of shaping how we in
Regulatory Affairs drive data integrations/migrations using
digital tools/automation?
If you are ready to take on the challenge...
...Regulatory Data Manager – RIMS Business Administrator
We are looking for a business administrator for our regulatory information management system (RIS). The RIS team, part of Lundbeck’s Global Regulatory Operations department, is responsible for the management...
Are you passionate about shaping future regulatory frameworks
and policies? Do you thrive in solving unique and complex problems
that have a significant impact on the development of future
medicines and devices? If so, we have an exciting opportunity...
...evt. med mulighed for deltid (min. 30 timer).
Har du interesse for og meget gerne erfaring med Regulatory Affairs – og helt optimalt med Marketing Compliance - og vil du gerne arbejde mere målrettet med Marketing Compliance, så er der måske her en udfordring til dig...
...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...
...Are you passionate about technical writing (incl. IP) and/or regulatory submission process and the subsequent Q&A process? Do you have experience from working with API manufacturing processes and/or the regulatory field? We are looking for a new colleague to join a team...
...Europe and the UK. As we continue to scale our impact, we are looking for a Senior Software Engineer with a focus on the finance and regulatory domains to join our Tech department in Copenhagen or Aarhus. For this position, you will report to Simon Stubben, our Head 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...
...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...
...Category: Regulatory Affairs
Country/Region: DK
Location: Odense, DK, 5260 Søborg, DK, 2860 One of our employees has taken the opportunity to work at one of our production sites for the next year. We are therefore looking for a replacement until end of April 2025...
...important role in ensuring that the cleanroom solution is state
of the art when brought into production, and compliant with
regulatory requirements now and in the future. You are responsible
for designing the facility surrounding the aseptic filling...
...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...
...take part in the
development of submission documents and be involved
in interactions with regulatory authorities.
~You will not be directly involved in the
clinical trial conduct but rather oversee the...
...on experience in validation within the
pharmaceutical or medical devices industry
~Demonstrate in-depth knowledge with regulatory requirements
for validation, including drug, combination, and device products
~Showcase a keen understanding of...
...responsibility of the team is:
- Provide specialized HVAC support within the aseptic manufacturing environment, ensuring compliance with regulatory requirements and company standards.
- Perform routine maintenance and troubleshooting of HVAC systems to ensure optimal...
...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...
...counterparties, run the KYC process, perform Sanction Screenings and to advise and support the business with in-depth knowledge of regulatory requirements pertaining to KYC and Sanctions. Your responsibility areas will among others be:
Know-Your-Customer (KYC),...
...successful execution of experiments.
Analyse, interpret, and model DMPK and PK/PD data, contributing to scientific publications and regulatory submissions.
Present research findings at internal and external scientific meetings and conferences.
What they are Looking...
...high complexity – e.g. KATA, A3 problem
solving, process optimizations, support, projects and ensuring
compliance with regulatory requirements, as well as ensuring the
validated condition of our production equipment.
Our area has
direct and...
...main purpose of
the department is support within product - and process
development, stability, specifications, and regulatory
documentation to the authorities of new drug products. We
currently support solid-dose products from production...
...improvements.
~Supporting and developing initiatives.
~Ensuring compliance with Novo Nordisk procedures, legal and
regulatory requirements.
Qualifications
Your experience includes:
~Preferably bachelor- or master’s degree within engineering...
...organisation and cross-functional stakeholders
(e.g., Strategic Project Teams, Trial Squads, Medical and
Science Teams, Regulatory Affairs etc.)
Qualifications
You will be a great asset to our team because you have:
• A MSc in Natural Science...
...Audits: Perform comprehensive audits of Danish-based clients' IT infrastructure, systems, and processes to assess compliance with regulatory requirements, industry standards, and best practices.
# Risk Assessment: Identify and analyze IT-related risks and...
...energy sector, with hands-on experience or a keen interest in sustainable transportation, renewable energy technologies, and related regulatory frameworks.
Experience: Proven experience in content creation, journalism, or a similar field, with a strong portfolio...
...System Operations and Compliance
In our department we are responsible for operation & maintenance, development, upgrades and regulatory compliance for more than 30 laboratory IT systems used within the non-clinical and clinical research and development area. We have...