Global Program Regulatory Manager

You will work 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, end of trial notifications, submission of CSR etc. You will be responsible to provide input into global regulatory strategy for early development compounds.You will contribute to regulatory innovations (e.g. novel therapeutic approaches, indications or endpoints, or any innovative regulatory pathways).

  • Chemie
  • Basel
  • Vollzeit
  • Temporär

Firmenprofil

Global Pharma Company

Arbeitsort

Basel

Arbeitsbeginn

June 2021

Motivation

Are you looking to work in a global growth company where you can make a real difference? Then you are right with us!

Ausbildung

BSc or MSc

Salärrahmen

As per industry

Erfahrungen

2-4 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, as well as with biologics is an asset.

Alter

Open

Sprachen

Englisch: Sehr gut

Spezielles

If you are interested then kindly send your resume to: v.agarwal@universal-job.ch

Vakanz-Nummer

P-13-7162

Personalberaterin

Vasudha Agarwal
Universal-Job AG
Kasinostrasse 32
5000 Aarau
Vasudha Agarwal Mail +41 62 834 63 58 V-Card
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