Regulatory Affairs CMC (Associate) Manager
Posted on Oct 23, 2020 by RM IT Professional Resources AG
Regulatory Affairs CMC (Associate) Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.
- Working experience in Regulatory Affairs in the pharmaceutical or biopharmaceutical sector
- Academic degree in science areas such as Chemistry, Pharmacy, Biochemistry, Biotechnology and Biology or equivalent
- Expertise in chemistry, biotechnology, analytics and pharmaceutical technology, exposure to drug development is a strong plus
- Proficiency with regulations, guidelines for NCEs and product life cycle maintenance combined with reasonable approach to risk assessment
- Proven track record of working with extended, multinational project teams and coordinating activities simultaneously on multiple projects under pressure of time
- Ability to critically evaluate data from a broad range of scientific disciplines paired with computer literacy
- Strong analytical, organizational and problem solving skills with attention to detail
- Languages: English, fluent in written and spoken
- Ensuring high-quality CMC documentation for HA submission in accordance with agreed CMC global regulatory strategies
- Assuring technical congruency and regulatory compliance as well as meeting agreed timelines and e-publishing requirements throughout project life cycle
- Preparing CMC responses to health authority questions during development, registration and product life cycle
- Identifying the required documentation for global submissions and negotiating the delivery of approved technical source documents in accordance with project timelines
- Defining content, quality and timeliness issues with source documents that may impact submission quality or timelines
- Improving knowledge regarding regulatory guidelines and requirements in all global regions as well as for new technical trends
- Participating as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned
- Providing support to the general department such as DRAGON support, to the annual and product renewal writing, source documentation and other database entry activities
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.
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