Manager CMC

Manager CMC wanted for our client in the pharmaceutical sector in Basel. Your experience/skills: Degree in science such as chemistry, pharmacy, biochemistry or equivalent Experience in drug / biopharmaceuticals and regulatory Functioning knowledge of chemistry / biotechnology and analytics or pharmaceutical technology. Drug development process Ability to work successfully within multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload along with organizational and interpersonal skills Languages: fluent English both written and spoken as well as good German knowledge Your tasks: Being the author of high quality CMC documentation as well as applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance and meeting timelines and e publishing requirements throughout project lifecycle 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 timeliness issues with source documents or any other potential authoring issues that may impact submission quality or timelines Building and maintaining solid working relationships with partners and customers as well as keeping knowledge up to date regarding regulatory guidelines and requirements Supporting the general department by coordinating and collecting source documentation needed along with other database entry activities Start: 10/2016 Duration: 14MM++ Location: Basel, Switzerland Ref.Nr.: BH 9803 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