Regulatory Affairs CMC Associate Manager
Posted on Sep 26, 2020 by RM IT Professional Resources AG
Regulatory Affairs CMC Associate Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.
- University degree in Chemistry, Pharmacy or a similar field
- Regulatory experience preferred and experience in drug biopharmaceuticals
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
- Experience of the drug development process desirable paired with the ability to critically evaluate data from a broad range of scientific disciplines
- Knowledge of regulations, guidelines for NCEs and product 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
- Languages: English, fluent in written and spoken, German is advantageous
- Authoring high quality CMC documentation for HA submission and applying agreed CMC global regulatory strategies assuring technical congruency and regulatory compliance
- Preparing CMC responses to health authority questions during development, registration and product life cycle
- Identifying the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
- Recognizing content, quality and timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines
- Keeping knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
- Establishing and maintaining sound working relationships with partners and customers as well as assuming activities in support of the general department such as DRAGON support, annual and product renewal writing
Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
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As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
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