Beschreibung
Associate Manage Regulatory Affairs CMC vacancy for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:
* Minimum 2 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
* Working knowledge of chemistry/biotechnology, analytics or pharma-ceutical technology. Knowledge of the drug development process desirable.
* Knowledge/experience of regulations, guidelines for NCEs and prod-uct 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.
.Your tasks:
* Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies.
* 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 potential authoring issues that may impact submission quality or timelines, as early as possible.
* Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
Start:
Duration: 04MM+
Location: Basel, Switzerland
Ref.Nr.: BH14669
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