Regulatory Affairs CMC Associate Manager wanted for our Basel based client in the pharmaceutical sector.
- Academic degree in either Chemistry, Pharmacy, Biochemistry, Biotechnology or anything equivalent
- At least 4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
- Strong understanding of the drug development process
- Profound knowledge of regulations and guidelines for NCEs and product life cycle maintenance desirable
- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
- Languages: fluent English both written and spoken
- 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 negotiate the delivery of approved technical source documents in accordance with project timelines
- Keeping knowledge up to date with regard to regulatory guidelines and requirements in all global regions
- Actively participate as a member of the global Regulatory Affairs CMC team by contributing to the regulatory strategy
Location: Basel, Switzerland
Does that sound interesting? Does that sound like a challenging opportunity to you? Then take the next step and send us your CV as a Word Document and a daytime contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
Going the extra mile…
New to Switzerland? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health – and social insurance
Work permit and much more
+41 58 356 06 06
Haben wir Ihr Interesse geweckt?
dann freuen wir uns auf Ihre vollständige Online-Bewerbung.