Regulatory Affairs CMC Manager
Posted on Jul 11, 2021 by RM IT Professional Resources AG
Regulatory Affairs CMC Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.
- Extensive Regulatory experience within drug/biopharmaceuticals
- Proficiency in chemistry, biotechnology, analytics or pharmaceutical technology, ideally with knowledge of the drug development process
- Capability of critically evaluating data from a broad range of scientific disciplines along with a reasonable approach to risk assessment
- Awareness of regulations, guidelines for NCEs and product life cycle maintenance
- Familiarity with extended, multinational project teams and ability to coordinate activities simultaneously on multiple projects
- Academic Degree in a scientific discipline such as Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or equivalent an advanced degree is desirable
- Languages: English fluent in written and spoken, Good skills in local site language desired is a plus
- Authoring CMC documentation for HA submission while applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance as well as meeting timelines and e-publishing requirements
- Preparing CMC responses to health authority questions during development, registration and product life cycle
- Identifying required documentation for global submissions and negotiating the delivery of approved technical source documents
- Recognising content, quality and timeliness issues with source documents or potential authoring issues that may impact submission quality or timelines
- Contributing to the regulatory strategy while identifying the critical issues and lessons learned while keeping up with regulatory guidelines and requirements in all global regions as well as with new technical trends
- Establishing and maintaining sound working relationships with partners and customers
- Supporting the general department with coordination, collection and storage of source documentation needed for direct submission to Has, annual and product renewal writing as well as other database entry activities
Location: Basel, Switzerland
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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