Junior GPRM/RegCMC Manager
Posted on Jun 28, 2021 by RM IT Professional Resources AG
Junior GPRM/RegCMC Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.
- Experience within the drug or biopharmaceutical environment, regulatory work experience is preferred
- Familiarity with chemistry and biotechnology analytics and pharmaceutical technology
- Knowledge of the drug development process is advantageous
- Capability to critically evaluate data from a wide range of scientific disciplines
- Strengths include strong interpersonal skills and good negotiation skills
- Academic degree the Science field like Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or any other equivalent education, an advanced degree is desirable
- Languages: English, fluent in written and spoken, German skills are desired
- Authoring high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies
- Assuring technical congruency and regulatory compliance as well as meeting agreed upon timelines and e-publishing requirements
- 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 according to project time lines
- Participating as a member in the global team by contributing to the regulatory strategy as well as identifying the key issues and lessons learned
- Establishing and maintaining sound working relationships with partners and customers
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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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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