Beschreibung
Senior Regulatory CMC Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:
- Several years of experience in regulatory, as well as drug/biopharmaceuticals environment
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
- Knowledge of the drug development process, regulations, guidelines for NCEs and product life cycle maintenance is of advantage
- Outstanding risk assessment skills, paired with the ability to critically evaluate data from a broad range of scientific disciplines
- Hands-on competency with collaborating successfully with extended, multinational project teams and coordinating several projects simultaneously
- Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent qualification
- Languages: English, fluent in written and spoken; any local language skills is a distinct advantage
Your tasks:
- Authoring high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance
- Preparing CMC responses to health authority questions during development, registration and product lifecycle
- Identifying the required documentation for global submissions and negotiating 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 potential authoring issues that may impact submission quality or timelines, as early as possible.
- Keeping knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
- Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
Start: ASAP
Duration: 09MM+
Location: Basel, Switzerland
Ref.Nr.: BH16648
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.
Going the Extra Mile.
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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