Regulatory Affairs Manager CMC (m/f)

Job type:
on-site
Start:
asap
Duration:
10 MM+
From:
Hays AG
Place:
Basel region
Date:
01/12/2017
Country:
flag_no Switzerland

Project description:
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This project is archived and not active any more.
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We are looking for a
Regulatory Affairs Manager CMC (m/f)

Reference: en
Start: asap
Duration: 10 MM+
Place: in Basel region
Branch: Herstellung von sonstigen organischen Grundstoffen und Chemikalien

Your tasks:
  • Prepare and support DMFs and NDA/MAA/BLA for customers (for small molecules, peptides, ACDs and/or microbial biotech products)
  • Support review, writing and/or approval of site specific regulatory documents
  • Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions
  • Keep documented regulatory project plans in line with best practice recommendations
  • Update functional leads and maintain transparency of information across regulatory functions
  • Facilitate and support the implementation of regulatory information management systems within the company and the creation of corresponding business processes within the RA team


Your qualifications
  • Life Sciences degree (i.e. chemistry, biology)
  • Profound experience in the pharmaceutical industry in regulatory affairs, especially CMC
  • Understanding of EU and US regulatory requirements for API
  • Experience in working with regulatory authorities
  • Experience in preparing and authoring Module 3 CTD i.e. for IND/IMPD, NDA/MAA
  • Fluency in English, further communication skills in German or French are of advantage, ability to manage priorities and work within tight schedules



Skills:
- Regulatory affairs manager