Description
We are looking for a
CMC Regulatory Intelligence Specialist (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Place: in West Switzerland
Branch: Wettbewerber
Your tasks:
- Support the Regulatory Intelligence Process, which consists of analysing, interpreting, communicating and acting on intelligence with respect to the CMC regulatory landscape
- Identify the impact of regulatory intelligence information on products, programs or regulatory practices
- Summarise, analyse and communicate regulatory intelligence and the potential impact
- Coordinate reviews of regulatory intelligence, ensuring alignment of all affected functions
- Prepare regulatory documents (quality), which form the basis of worldwide submissions such as applications for variations, line extensions, amendments and renewals of existing authorisations, responses to questions from authorities
Your qualifications
- Bachelor's degree (or equivalent)
- Extensive experience in the pharmaceutical industry and ideally in the biotech field
- Extensive experience in regulatory affairs, research and development or quality assurance/compliance
- Knowledge regarding global health authorities, regulations, product approval and lifecycle processes for major markets
- Ability to effectively communicate and summarize complex issues verbally and in writing
- Ability to work independently and focus on multiple issues/deadlines simultaneously
- Fluency in English
Skills:
- Regulatory affairs manager