Regulatory submission Jobs

Director, Biostatistics

Basel, Basel-Stadt

...and figures for study reports and manuscripts. Reviews regulatory documents for accuracy and appropriateness of statistical interpretations. Act as statistical
vor 16 Tage in Jobleads

Medical Director/Exec. Director, Gastrointestinal (GI) Immun

Basel, Basel-Stadt

...submission through drug registration (including advisory committee and scientific advice group meetings). Translational Research (TR; indication seeking...
vor 26 Tage in Jobleads

Clinical Development Medical Director (Global Health)

Basel, Basel-Stadt

...Clinical Development Medical Director (CDMD) is the Global clinical leader of defined and assigned program level activities and deliverables (e... submission...
vor 8 Tage in Jobleads

Drug Safety Case Manager

Basel, Basel-Stadt

...location. Responsibilities: Responsible for complete case processing: triaging, data entry, coding of AEs, narrative writing, quality control and submission...
vor 14 Tage in Jobleads

Drug Safety Case Manager

Basel, Basel-Stadt

...Standard Operating Procedures (SOPs), and guidelines. Key Responsibilities: End-to-End Case Processing: Manage AE reports from intake to submission...
vor 26 Tage in Jobleads

Drug Safety Case Manager (6447)

Basel, Basel-Stadt

...regulatory authorities; Identifying missing information and initiating follow up requests in collaboration with Drug Safety Physicians; Performing and...
vor 27 Tage in Jobleads

Global Safety Scientist

Basel, Basel-Stadt

...regulatory interactions and defence, and geo-expansion beyond initial License Applications (NDA/BLA). High quality written and spoken English...
vor mehr als 1 Monat in Jobleads

Clinical Development Medical Director - Cardiology

Basel, Basel-Stadt

...and reporting of quality data. The Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (e... submission...
vor 12 Tage in Jobleads

Drug Safety Case Manager

...months. Responsibilities: Manage adverse event case reports, including triaging, data entry, coding of AEs, narrative writing, quality control, and submission...
vor 27 Tage in Jobleads

Global Product Safety Scientist

Basel, Basel-Stadt

...regulatory authorities and other sources requiring input from GPV. Be the safety representative in clinical study teams, including providing safety input to...
vor mehr als 1 Monat in Jobleads

Director of Non-Clinical PK/PD

Allschwil, Basel-Landschaft

...development, along with experience in regulatory submissions and interactions. Relevant expertise in immuno-oncology. Additional expertise and experience in
vor mehr als 1 Monat in Jobleads

Global Program Head

Basel, Basel-Stadt

...regulatory / market access / commercialization requirements particularly for US Clinical background relevant to the programs in the development franchise...
vor 12 Tage in Jobleads

Clinical Development Medical Director - Renal *80-100%

Basel, Basel-Stadt

...brochures, and informed consent forms. Determine appropriate safety monitoring and risk management strategies. Ensure compliance with all applicable regulatory...
vor mehr als 1 Monat in Jobleads

Freelance Senior Quality Assurance (QA) Specialist – MedTech

...is a leading company in the MedTech industry, dedicated to developing innovative products that meet the highest standards of safety, quality, and regulatory...
vor mehr als 1 Monat in Jobleads

Global Product Safety Scientist

Basel, Basel-Stadt

...submission activities. Lead the collection of material for periodic reports e... PSURs and DSURs and contribute to the risk evaluation and the benefit-risk...
vor mehr als 1 Monat in Jobleads

Scientist Lab Technician Assay Development (m/f/d)

Risch-Rotkreuz, Zug

...studies, stability studies, and technical performance verification studies; and documentation of analytical performance for product labeling and regulatory...
vor 16 Tage in Jobleads

Clinical Scientist, Early Clinical Development

Boudry, Neuenburg

...submission) Submit clinical documents to TMF. Reporting Relationship Director, Clinical Science Early Clinical Development (HOCT) Qualifications Specific...
vor 28 Tage in Jobleads

Drug Safety Case Manager

...location. Responsibilities: Responsible for complete case processing: triaging, data entry, coding of AEs, narrative writing, quality control and submission...
vor 26 Tage in Jobleads

NPP Tender Manager

Wettingen, Aargau

...in the preparation of bids for Nuclear Service Offers. As the leader, you will have an overview of the enquiries received, bid preparation status, submission...
vor mehr als 1 Monat in Jobleads

Statutory Controller

Allschwil, Basel-Landschaft

...regulatory authorities. 5+ years of experience in statutory accounting, tax, or financial compliance, ideally in a multinational organization or audit firm...
vor 14 Tage in Jobleads

Global Program Clinical Head - Cardiovascular, Metabolism

...submission dossiers required Cardiovascular disease expertise Advanced knowledge of assigned therapeutic area required, with the capability to innovate in...
vor 14 Tage in Jobleads

Global Program Head, Neuroscience (MD, PHD)

Basel, Basel-Stadt

...regulatory/market access/commercialization requirements, particularly for the US. Clinical background relevant to the programs in the development franchise...
vor mehr als 1 Monat in Jobleads

Associate Director, Global Labeling Product Leader

Allschwil, Basel-Landschaft

...of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Regulatory...
vor 17 Tage in Jobleads

Clinical Development Medical Director - Renal *80-100%

Basel, Basel-Stadt

...brochures, and informed consent forms. Determine appropriate safety monitoring and risk management strategies. Ensure compliance with all applicable regulatory...
vor mehr als 1 Monat in Jobleads

Senior Scientist Analytical Development Synthetic Molecules

Basel, Basel-Stadt

...methods, analysing raw materials, intermediates, active, and a variety of dosage forms of synthetic molecule development products and preparing regulatory...
vor mehr als 1 Monat in Jobleads