...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...
...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 5 dage siden
...background, and interest, you will also take part in non-compartmental PK/PD analysis, interpretation of data, and authoring of regulatory documents.
We are looking for an engaged, detail-oriented, and result-focused colleague who is passionate about bioanalysis and...
...Oversight and QC of the TMF.
Planning and participating in Monitor and Investigator Meetings.
Support IRC/IEC and regulatory submissions, as needed.
Contribute to Ascendis clinical Quality Management System by contributing to clinical SOPs.
Your...
...compliance training consistent with Ascendis Pharma policies, applicable laws, and industry standards.
Stay updated on relevant regulatory changes and industry standards in the healthcare field.
Conduct Compliance monitoring.
Qualification and skills:
You...
...enjoy leading drug development for rare conditions? Are you a medic with experience designing clinical trials and interacting with regulatory authorities?
If so, now is your chance to join Ascendis Pharma as our new Senior Medical Director, Clinical Development,...
...department subject matter expert for CDM within the assigned clinical studies
Ensure the quality of clinical data meet standards for regulatory submissions
Manage, collaborate, and act as the primary point of contact with CRO partner to ensure quality deliverables...
...validated state of our commercial drug products
Supporting validation of transportation activities
Involved in authoring regulatory documentation for filing in new countries
Supporting manufacturing activities at the CMOs, including follow up on deviation,...
...of the team.
Your key responsibilities will be:
Maintaining and improving our applications, which includes maintaining regulatory compliance (GxP) in an agile setting.
Ensuring understanding of business processes and needs and translating these to technical...
...will play a crucial role in the validation of shipping processes for Cold Chain pharmaceutical products, ensuring compliance with regulatory requirements and industry standards. You will utilize your expertise in shipping validation to assess and validate shipping lanes...
...efforts, including medical expert support of product pre-launch/launch/post launch.
Works closely with Compliance, Legal and Regulatory to ensure that all Global Medical Affairs activities and services are fully compliant with Ascendis SOPs as well as global...
...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...
...direct reports thrive and are developed to maintain a high scientific level in drug product manufacturing
Involved in writing regulatory documentation for BLA/NDA/MAA and main responsible for filing in all other markets for drug product
Involved in scientific...
...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...
...Join a fast-changing environment where people do their best to get Novo Nordisk products approved across the globe. In Global Regulatory Affairs, o ur people have a unique combination of scientific insight and ability to navigate many external requirements and stakeholders...
...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, we invite you to become a part...
...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...
...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...
...and/or procedures for the partner collaboration, for i.e., sharing of documents, timely notifications, commitments and for other regulatory obligations, etc.
Your professional qualifications
We are seeking a skilled and motivated person to join our team, that can...
...have experience from either RA, CMC, QA, and/or QC – or any other relevant area? Do you possess a natural interest and flair for regulatory guidelines? Do you enjoy being part of a team where you together build and work on the timely delivery of successful submissions?...
...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...
...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 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...
...navigate political agendas and external stakeholders? If yes, you might be the new Data Science Policy Specialist we are looking for in Regulatory Affairs.
We are seeking an enthusiastic specialist to be at the forefront of bridging the gap between advances in data...
...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 for you to join our...
...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...
...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...
...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),...
...Possess hands-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 validation...