Regulary Affaires Manager CMC

Basel-Country  ‐ Onsite
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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
Start date
11/2014
Duration
6 months
From
Real Staffing
Published at
30.10.2014
Project ID:
800117
Contract type
Freelance
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