Description
Regulatory Affairs CMC Associate Manager with profound Basel knowledge wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- Science Degree in Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or equivalent
- Regulatory, drug/biopharmaceuticals experience, chemistry/biotechnology, analytics or pharmaceutical technology coupled with knowledge of the drug development process
- Knowledge of guidelines for NCEs and product life cycle maintenance desirable coupled with the ability to critically evaluate data from a broad range of scientific disciplines
- Strong planning, communicating and organisational skills with an reasonable approach to risk assessment
- Languages: fluent English both written and spoken, German is a plus
Your tasks:
- Composing high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, and e-publishing requirements throughout project lifecycle
- Preparing CMC responses to health authority questions during development, registration and product lifecycle
- Identifying content, quality and timeliness issues with source documents or other po-tential authoring issues that may impact submission quality or timelines
- Keeping knowledge up to date regarding to regulatory guidelines and requirements in all global regions as well as actively participating in the global team as well as establishing and maintaining sound working relationships with stakeholders
- Assuming activities in supporting the general department such as annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs and other database entry activities
Start: ASAP
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH13073
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