Exigences

Niveau d'étude requis
Master
Expérience requise
Entre 1 et 3 ans
Connaissances linguistiques requises
anglais

Détails

Lieu
Bâle-Ville
Horaires de travail
Temporaire
Secteur
Biotechnologie / Chimie / Phar...
Professions
Affaires réglementaires

Description

Our client, an internationally renowned Pharmaceutical company is recruiting. On its behalf we are now looking for a qualified junior CMC Regulatory Affairs Associate to work in the Basel area on a full-time, temporary basis, for at least the next 12 months.

Client Details

Our client, an internationally renowned Pharmaceutical company is recruiting. On its behalf we are now looking for a qualified junior CMC Regulatory Affairs Associate to work in the Basel area on a full-time, temporary basis, for at least the next 12 months.

Description

In this position you will be supporting a Basel-based team with regulatory submissions. Your responsibilities will include:

  • Author high-quality CMC documentation for Health Authority submission with support and guidance, in-line with strategies

  • Prepare CMC responses to health authority questions during development, registration and product lifecycle

  • Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines

  • Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines

  • Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends

Profile

  • Advanced Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

  • Fluent in English, and good knowledge of German/French

  • Regulatory experience preferred, and/or experience in drug/biopharmaceuticals

  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology

  • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload

Job Offer

Are you currently looking for a position within an international operating, dynamic business environment and enjoy communication and working together with different nationalities and teams? We look forward to receiving your application!

Page Personnel
Non disponible

Informations de contact

Page Personnel
Robert Rutherford
0z 0z 7k- rr 07g
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