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Archiviertes Projekt - Global Program Regulatory Manager (GPRM), Oncology

Firmenname für PREMIUM-Mitglieder sichtbar

  • Mai 2021
  • nicht angegeben
  • CH-Basel
  • auf Anfrage
  • 04.05.2021
  • BBBH16970_1620136649

Projektbeschreibung

Global Program Regulatory Manager for a globally operating Basel based company in the pharmaceutical sector.
Your experience/skills:

* 2+ years of regulatory experience, spanning activities in early development and Phase I-IV, preferably with a strong knowledge and regulatory operational expertise of EU regulatory affairs- additional knowledge of other regions is an asset
* Scientific knowledge and any additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline
* Outstanding interpersonal, communication, negotiation, problem solving skills and ability to work in a global environment
* Advanced degree in a related scientific field with requisite demonstrated experience and capability
* Languages: English, fluent in written and spoken

Your tasks:

* Providing input into global regulatory strategy for early development compound
* Contributing to regulatory innovations, such as novel therapeutic approaches, indications or endpoints, or any innovative regulatory pathways
* Helping with identifying regulatory issues, gaps, and tradeoffs affecting optimal and timely submission and approval
* Working in a high-performing multi-disciplinary Team to ensure submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), and CTA/ IND related maintenance activities such as amendments, annual safety reporting, Investigator Brochures
* Participating in regulatory activities in planning early Health Authority (HA) interactions and in negotiations with HA to address queries on INDs and CTAs

Start: 06/2021
Duration: 09MM+
Location: Basel, Switzerland
Ref.Nr.: BH 16970
Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:

* All administrative questions
* Finding an apartment
* Health - and social insurance
* Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

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