Zoekresultaten: 30 vacatures
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Als regulatory researcher werk je in het team van Ana Hidalgo-Simon, een regulatory specialist met jarenlange ervaring bij het Europees Geneesmiddelenbureau...
Aanbevolen
Fulltime
Fysiekwerk
...recipe content for the Leiden manufacturing facility. We ensure that automated systems are fit for intended use and follow applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle.
what we offer
~€650...
Aanbevolen
Stage
Tijdelijk
€ 75 - € 80 per uur
...Help with the development of a clinical program with novel CAR-T therapies in various indications towards clinical trials and regulatory approval.
Key Skills and Requirements:
Master's degree or PhD in (Bio-)Medical or life sciences.
Previous experience...
Aanbevolen
Met contract
...averydennison.com .
Job Description
As a Product Compliance Intern, you will gain a deeper insight into the current regulatory landscape. During this internship you will work on a project related to the optimization of the internal tools and data management...
Aanbevolen
Stage
Fulltime
Op afstand werken
...all corporate and site policies/procedures regarding personal conduct, Health, Safety, and Environment (HSE), and Product Safety & Regulatory Affairs (PSRA) standards, ensuring team compliance with AN HSE and compliance policies.
What do you need to have to be...
Aanbevolen
...biologics manufacturing or analytical testing is highly desirable.
Familiar with and able to interpret relevant regulations, regulatory agency inspection expectations (e.g. FDA, EMA, etc.) is required.
Excellent computer skills and knowledge of MS Office and Document...
Aanbevolen
Fulltime
Op afstand werken
Ploegendienst
...drive customer acquisition
Ensure the offering is compliant to the legislation in the Dutch market
Be informed about the regulatory situation in The Netherlands and participate in updates and calls with external lawyers as well as the internal Compliance and Legal...
Aanbevolen
Thuiswerk
...processes by means of efficient compliance and effective decision support. Brill is bound by an extensive and constantly changing set of regulatory requirements and standards such as IFRS, tax regulations and other requirements that are locally relevant in the jurisdictions in...
Aanbevolen
Thuiswerk
...between NEM and the client.
Safety and Compliance: Ensure that all control systems and operations comply with safety standards and regulatory requirements. This includes conducting safety audits and implementing best practices to prevent accidents and ensure a safe...
Aanbevolen
...Contributing to the quarterly and annual closing, collecting and processing data files and creating consolidated insights;
Implementing (regulatory) changes and improvements within the reporting cycle.
What do we offer?
We offer the opportunity to become an expert in...
Aanbevolen
...popcorn journey and building new distribution relationships with premium FMCG brands to creating further awareness with respect to regulatory compliance and setting up a logistics framework for our company in Miami your days in Legal may look something like the following...
Aanbevolen
Stage
Met contract
Fulltime
...CNC) material receipt to manufacturing delivery, thereby ensuring adherence by the team to Standard Operating Procedures (SOPs), regulatory requirements and company policy while performing job functions.
Key Responsibilities
Develop and manage Warehouse team member...
Aanbevolen
Op afstand werken
Ploegendienst
...team, inform, and advise if required.
~Support, Deliver and Maintain the CMC dossiers by providing strategic and tactical input in regulatory CMC dossiers (e.g., Quality IMPDs, Module 3 and QoS documents for INDs or marketing authorizations, CMC lifecycle management...
Aanbevolen
...comprehensive documentation for automation systems, including specifications, design documents, and test protocols to ensure compliance with regulatory requirements.
# Review and Validation: Participate in the review and validation of automation systems, ensuring adherence to...
Aanbevolen
Met contract
Per direct beginnen
...negotiate with external authorities and governmental bodies.
Coordinate the governmental inspections.
Maintain and improve the EHS regulatory compliance process and the EHS Document Control process
Subject Matter Expert of EHS legislation
Functie eisen...
Aanbevolen
Interim
ZZP
...Knowledgeable on the CMC requirements applicable to ATMPs in clinical phase and beyond
~Knowledge of GMP, ICH guidelines, pharmacopeia and regulatory requirements, preferably within the field of gene therapy and ATMPs
~Be aware of the needs and perspectives of a Point-of-Care...
Voor uitvoerders
Met contract
...ongoing initiatives.
Lab execution for Research and Manufacturing.
Equipment Maintenance
Quality Assurance & Control
Regulatory Compliance
Data Collection & Analysis
Documentation & Reporting
Minimum internship term of 6 months.
Final year of graduation...
Stage
...maintaining relationships with Key Opinion Leaders (KOLs) and external studies and staying abreast of the scientific, competitive, and regulatory landscapes.
Ensure that study plans and reports are compliant with GCP and adverse events are appropriately reported.
Write...
Fulltime
Stage
...lead, manage and develop a team of experienced BD&L professionals who:
Together with Preclinical Research, Clinical Development, Regulatory Affairs and Commercial Strategy develop and enhance the ambitious strategy for external innovation for Pharming Group N.V....
Stage
Met contract
...Development,
MSAT, Supply Chain, and CMC leadership to ensure Product Quality
standards are met and in compliance with applicable regulatory
requirements and specifications
~Provides product quality
oversight and strategic input over product and analytical...