Description
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
Did this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number.
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.
Going the extra mile…
New to Switzerland? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more