Regulatory Affairs CMC Associate Manager

Regulatory Affairs CMC Associate Manager wanted for our Basel based client in the pharmaceutical sector. Your experience/skills: 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 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 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 Start: 11/2016 Duration: 12MM++ Location: Basel, Switzerland Ref.Nr.: BH9838 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