- Experience Level
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for a CMC Manager to be based in Basel for a contract position.
As an ideal candidate you will provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
- 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, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle;
- Preparing CMC responses to health authority questions during development, registration and product lifecycle;
- Identifying the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
- Identifying 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 possible;
- Keeping up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends;
Qualifications and Experience:
- Bachelors degree/Advanced degree in Sciences;
- 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.
- Relevant working/residency permit or Swiss/EU-Citizenship required.
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