Description
We are looking for a
Regulatory Affairs Manager CMC (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: in the 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 LPB 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
- Medical writer
Keywords: Regulatory Affairs CMC API Pharma Reg. affairs documents DMF NDA MAA BLA