Regulatory CMC Manager

Author high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance throughout project lifecycle. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends. Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues. Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs.

  • Chemie
  • Basel
  • Vollzeit
  • Temporär

Firmenprofil

Global pharma company

Arbeitsort

Basel

Arbeitsbeginn

Asap

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

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

Salärrahmen

As per the industry

Erfahrungen

Regulatory experience preferred, and/or experience in drug/biopharmaceuticals. Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.

Alter

Open

Sprachen

Deutsch: Von Vorteil
Englisch: Sehr gut

Spezielles

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

Vakanz-Nummer

P-13-6941

Personalberaterin

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