Das sind deine Aufgaben:
Du verantwortest regulatorische Fragestellungen rund um Energie und verfolgst die politische und regulatorische Entwicklung
Aus deinen Analysen leitest du Handlungsempfehlungen ab, erstellst Risikobewertungen, unterstützt die Strategiedefinition...
Suggéré
Travail à domicile
...covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a:
Drug Regulatory Affairs Clinical Trial Manager 100% – 5716 LBD
10-month contract based in Basel area with possibility for extension....
Suggéré
...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...
Suggéré
Temps plein
Das sind deine Aufgaben:
Du verantwortest regulatorische Fragestellungen im Rahmen der Strom- und Gasversorgungsgesetzgebung und verfolgst die politische und regulatorische Entwicklung
Aus deinen Analysen leitest du Handlungsempfehlungen ab, erstellst Risikobewertungen...
Suggéré
...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...
Suggéré
Temps plein
...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...
Suggéré
Emploi postdoc
CDD
Durée déterminée
...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...
Suggéré
...requires careful consideration. In most cases, the therapies investigated in clinical trials are not yet approved by regulatory agencies like the Food and Drug Administration (FDA) in the United States. The benefits and risks of taking investigational drugs are not...
Suggéré
Biogen
Baar ZG
il y a 2 jours
...Act as Responsible Person (RP) delegate for Commercial Biologics Drug Substances (DS), Parenteral Drug Products (DP), Parenteral... ...compliance.
Experience in clinical products manufacturing and/or
regulatory is an asset. Knowledge of medical device regulations and manufacturing...
Suggéré
...working practices within the matrix structure.
Support the regulatory teams, Market Access and Reimbursement activities in the EPM markets... ...Doctor degree is mandatory.
Proficient in all aspects of drug development, GCP and regional regulations - including the...
Suggéré
...portfolio of innovative medicines.
Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline... ...within the UK.
Provide medical expertise in all regulatory, early access and reimbursement approval processes.
Partner...
Suggéré
Temps plein
Temporaire
...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...
Suggéré
Temps plein
...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...
Suggéré
Temps plein
...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...
Suggéré
...Senior Software Engineer – 5860 URA
Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in... ...support test automation required by quality practices as well as regulatory compliance needs.
~Team mindset, focus on objectives, and understanding...
Suggéré
Remote job
...Commissioning & Qualification (C&Q) compliance of an aseptic fill-finish drug product manufacturing facility CAPEX project. Main focus will... ...Responsibilities:
·Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
·Ensuring C&Q compliance...
...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...
...curiosity meets purpose
Neuroscience
Connecting the dots in neuroscience
Science & Innovation
Multiple modalities in drug development
See all Stories
Disease Areas
We believe no other disease area holds as much need or promise for medical...
Biogen
Baar ZG
il y a 2 jours
...interested in
Responsibility
Increasing diversity in clinical trials: A collaboration with Tufts Center for the Study of Drug Development
Multiple Sclerosis
The hidden face of MS
Lupus
Living with lupus: Hazura’s story
2021 Year in...
Biogen
Baar ZG
il y a 2 jours
...improvement, and development, while approaching problems from new perspectives
Providing support for the manufacturing of clinical supply drug substance, including resupply activities
Operating equipment according to batch records, sampling plans, and standard operating...
Temporaire
...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...
...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...
Recrutement immédiat
...establishing Quality Agreements where needed.
~Interface between quality/regulatory/compliance personnel and operations to identify applicable... ..., 1 year as Lead Auditor
~Knowledge and understanding of drug product development, manufacturing processes, as well as...
...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...
...inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera’s...
Temps plein
Temporaire
Recrutement immédiat
Remote job
...Quality and Safety Standards
Be knowledgeable and a subject matter expert in both MSD’s internal engineering standards and in country regulatory requirements.
Project Management
Project execution and oversight to ensure compliance with procurement policies and...
Travail à domicile
...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)...
Temporaire
Rotkreuz, Risch, ZG
il y a 10 jours
...improvement, and development, while approaching problems from new perspectives
Providing support for the manufacturing of clinical supply drug substance, including resupply activities
Operating equipment according to batch records, sampling plans, and standard operating...
Temporaire
Recrutement immédiat
...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...
Temporaire
Apprentissage
...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...