Regulatory CMC Associate Manager: biotechnology, analytics

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
11 months
Von:
Sentinel IT LLP
Ort:
Basel-Stadt
Eingestellt:
30.01.2015
Land:
flag_no Schweiz
Projekt-ID:
842838

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Regulatory CMC Associate Manager: biotechnology, analytics, German

I have a long term freelance engagement within one of the worlds most successful and innovative companies.

Please find a brief version of the job spec below with a detailed version available on request:

Job Description:

Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.

Minimum: Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.

1.0-4 years in regulatory preferred, and/or experience in drug/bio-pharmaceuticals
2.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.
3.Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.

Regulatory CMC Associate Manager: biotechnology, analytics, German