Description
Regulatory Affairs CMC Associate Manager wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- University degree in Science, for example Chemistry, Biochemistry, Pharmacy, Biotechnology or Biology
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology, preferably with know-how of regulations, guidelines for NCEs and product life cycle maintenance
- Experience in the Regulatory field or in drug or biopharmaceuticals is a big plus
- Ability to critically evaluate data from a broad range of scientific disciplines, understanding of the drug development process is advantageous
- Competency to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects
- Languages: fluent English both written and spoken
Your tasks:
- Writing high-quality CMC documentation for Health Authority (HA) submission, applying agreed CMC global regulatory strategies as well as assuring technical congruency and regulatory compliance
- Preparing CMC responses to health authority questions during development, registration and product lifecycle as well as identifying required documentation for global submissions and negotiating the delivery of approved technical source documents in accordance with project timelines
- Specifying content, quality and timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines
- Participating as a member of the global team by contributing to the regulatory strategy in addition to keeping knowledge up to date with regard to regulatory guidelines and requirements in all global regions
- Supporting general department such as the Drug Regulatory Affairs Compliance System for Global Regulatory, writing annual and product renewal along with ensuring coordination, collection and storage of source documentation needed for direct submission to HAs
Start: ASAP
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH13350
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a 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