Beschreibung
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