Description
My client an internationally present company is currently looking for a CMC Specialist. This will be a 6 month project in Muttenz (near Basel). They are looking for the following requirements.Job description (short version):
- Experienced Regulatory Affairs Manager with strong CMC expertise, preferably for inhalation products (will be difficult to find, so strong CMC expertise is then more important), who can provide assessments of CMC variations and filing requirements, change controls, support CMC strategies for new products; general RA support.
- Train our regulatory affairs associate
- Manage preparation, compilation and maintenance of regulatory filings
- Develop regulatory/registration strategies, advise on regulatory requirements and ensure implementation into product development plans
- Provide regulatory support to clinical program design and conduct of clinical studies
If you are interested please feel free to contact me and we can discuss this position in more detail
Sebastian Spaniol
s.spaniol'@'realstaffing.com