...About the role
As Regulatory Affairs Manager, you will be responsible for all drug regulatory affairs matters for the assigned indication group and will act as an interface between global Regulatory Affairs departments and Swissmedic to obtain new marketing authorizations...
Consigliato
Tempo pieno
...Description
About the role:
The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is... ...of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA)/centralized Marketing Authorization...
Consigliato
Tempo pieno
Contract
Posted 2 weeks ago
Recruiter: Anil Dahiya
QA Expert – Drug Development – 5890 ADA
Our client, an innovative and... ...the partnerships.
~Notify management of potential quality and regulatory issues in close collaboration with CMOs.
~Ensure a GMP/GDP compliant...
Consigliato
...researchers from more than 120 different countries.
Postdoc Position in Human Organoid-Based High-Throughput Systems for Anti-Infective Drug Discovery
Your mission :
We are excited to announce an open postdoc position on a groundbreaking project focused on the...
Consigliato
Lavoro post-doc
CDD
Tempo determinato
...Recruiter: Anil Dahiya
Technical Project & Product Lead – Drug Product (Oral Dosage) – 5752 ADA
Our client, an innovative... ...execution of the overall CMC strategy.
~Ensure compliance with regulatory guidelines.
Qualifications and Experience:
~Relevant Swiss...
Consigliato
...commercial products. Responsibilities also include oversight of Drug Substance (DS) and Drug Product (DP) global change control... ...across the End-to-End Supply Chain and collaborates with Planning, Regulatory Sciences, and Regulatory CMC to ensure that change control and...
Consigliato
Tempo pieno
...accountabilities, for providing hands-on legal commercial support to medmix Drug Delivery business segment and provide corporate and governance... ..., including preparing the Annual General Meeting, address regulatory aspects of Swiss listed companies.
~ Demonstrated ability to...
Consigliato
Tempo pieno
...assessments
Possess and maintain knowledge of current global GMP regulatory requirements and industry trends to ensure compliance at... ...is preferable.
At least 5 years of experience working with drug substance/drug product manufacturing, Quality Control and/or Quality...
Consigliato
Tempo pieno
...controls.
~Notify CMC team and management of potential quality, regulatory and lead time issues.
~Participate, represent, and defend... ...pharmaceutical industry
~3-6 years of experience in quality assurance of drug substance and/or drug product
~Knowledge and understanding of...
Consigliato
...skill development training programs.
Our client, a pioneer in Drug Discovery and Development and a leader in Personalized... ...deficiencies, propose solutions, and effectively interpret and apply regulatory requirements; excellent communication skills; ability to collaborate...
Consigliato
...and technological excellence, particularly concerning parenteral drug products.
~Foster close collaboration with cross-functional... ...transfers, and support supply activities.
~Uphold compliance with regulatory requisites and aid in inspections by contributing to filing...
Consigliato
...genomics data and contextualizes results to advance understanding of drug mechanism of action and pharmacodynamics in clinical trials and... ...genomics biomarker data in line with best practices, GDPR, and regulatory requirements.
~Presents and publishes genomics data analysis...
Consigliato
...coordination with the content manager, subject matter experts, and project teams.
Ensures that quality targets, timelines, and regulatory requirements are respected.
After translation, creates target language versions of deliverables (in all appropriate formats)....
Consigliato
Tempo pieno
World leader for manufacturing drug delivery systems|Temporary 6 months contract About Our Client: For our client, an international manufacturer of advanced drug delivery systems in Zug area, we're looking for a (Senior) Mechanical Test Engineer (40-80%) for primary packaging...
Consigliato
Temporaneo
Apprendistato
Remote job
...fostering the development of patient-centric drugs and facilitating the introduction of... ...activities for liquid and lyophilized parenteral drug products, encompassing small molecules,... ...(e.g., development reports, regulatory document support), ensuring meticulous attention...
Consigliato
...Solid knowledge of cGMP requirements, EU/FDA regulations and compliance.
Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus.
Ability to develop effective working relationships...
Lavoro urgente
...Head Finance & Accounting
Tasks
Manage and oversee the companys financial records ensuring accuracy and compliance with regulatory standards
Active and independent preparation in monthly quarterly and annual financial statements in accordance with Swiss Code...
Tempo pieno
Orario flessibile
...research analysts, traders, and other team members to develop innovative trading strategies and solutions.
Stay abreast of regulatory developments and industry trends affecting commodities derivatives markets.
Qualifications:
Minimum of 3-5 years of...
Tempo pieno
Selby Jennings
Sarnen OW
3 giorni fa
...Training, Reporting)
Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departments. Information gathering from respective stakeholders including...
Temporaneo
Rotkreuz, Risch, ZG
10 giorni fa
...Excellent quantitative skills and meticulous attention to details - Strong communication abilities and teamwork skills - Knowledge of regulatory frameworks related to cryptocurrency trading is advantageous
By applying for this position, I consent to the Swisslinx Group...
Tempo pieno
Swisslinx
Zugo ZG
1 giorno fa
...LIMS, SDMS, and LES solutions.
Customize the system to meet the specific needs of the organization.
Ensure compliance with regulatory standards (GxP, FDA, etc.) throughout the implementation process.
Change Management:
Develop and execute change management...
...and resolve or escalate issues in a timely manner
Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirements
Work with sites to...
Temporaneo
Rotkreuz, Risch, ZG
11 giorni fa
...bridge financing provider, annual statements to funds' Swiss Representative
# Support in delivery of investor-level & fund tax and regulatory reporting/filing with third-party service providers
# Manage and ensure accuracy of fund vehicle data transfers between service...
Tempo pieno
...von rund 40 schnell wachsenden Schweizer Banken bei. Verfolgung der Entwicklung der bankfachlichen Module, neuer Innovationen, Regulatorien und ihrer Anpassung an die Bedürfnisse der KundenBeratung der Kunden bei der ständigen Optimierung der GeschäftsprozesseIntegration...
...Engineer III will be leading, facilitating, or coordinating all activities pertaining to tech transfer within the Switzerland internal drug substance manufacturing site. Also, this person will lead technology transfer assignment and prioritization for drug product...
Tempo pieno
...advising Operations Planner on label strategy for a clinical packaging job.
Reviewing county-specific label text on accuracy and regulatory requirements.
Handling of randomization schedules for clinical studies.
Reviewing and release of label batch record...
Temporaneo
Apprendistato
...Science Technology and the Institute for Food, Nutrition and Health. Broad research objectives of the group are to promote food and drug safety by elucidating mechanisms of toxicity. Researchers work to define relationships between chemical structures, molecular...
Tempo determinato
...Permanent
Job Description:
The Electrical Avionics Compliance Verification Engineer is responsible for ensuring compliance with regulatory requirements and standards related to avionics systems for aircraft. This role involves working on electrical systems and...
Tempo pieno
...Responsible for compliance application of the change and the corresponding KPIs
Responsible for maintenance and preparation of the regulatory correct documentation, for example Change Request/Change
Notification, Design Master Record, Design History File etc....
Temporaneo
Apprendistato
Rotkreuz, Risch, ZG
4 giorni fa
...English & German
Proficiency in accounting software (Infoniqa) and MS Office (proficient in Excel)
Familiarity with GAAP and regulatory requirements and with IFRS experience being highly beneficial
Strong attention to detail analytical and able to work on...
Tempo pieno
Orario flessibile