Description
CMC Manager vacancy requiring profound Regulatory(CMC) knowledge for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:
- 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
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Your tasks:
- Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and reg-ulatory compliance
- Prepare CMC responses to health authority questions during development, registration and product lifecycle.
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Identify content, quality and/or timeliness issues with source documents, or any other po-tential authoring issues that may impact submission quality or timelines, as early as pos-sible.
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
Start: ASAP
Duration: 9MM+
Location: Basel, Switzerland
Ref.Nr.: BH14794
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As a preferred recruitment agency for Swiss banks, international insurance, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern and other regions in Switzerland every day.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
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