Regulatory Affairs Scientist (Fixed-term contract
On behalf of an International Company based in Geneva, we are currently looking for a:
Purpose of the role:
Under the responsibility of the Global Head Regulatory Affairs Infectious Disease /OTX, you will be part of the Technical Regulatory Affairs and will support timely preparation of high quality drug substance and/or drug product Quality (CMC) documentation, to support global regulatory submissions.
Your responsibilities:
- Contribute to the definition of the CMC regulatory strategy for new registration and life cycle activities
- Write an update high-quality CMC documentation, respecting CMC regulatory strategies
- Coordinate and prepare CMC responses to health authority questions
- Coordinate and perform compliance check, gap analysis and dossier updates
- Perform regulatory assessment for change control
- Act as Regulatory liaison with manufacturing plant, quality and RD
Your profile:
- Scientific background (pharmacy, chemistry, biochemistry)
- 3 to 8 years experience in Regulatory Affairs
- Fluent in English French
- Open minded, team spirit, curious, organised, accurate, autonomous, quick learner
- Strong adaptability and excellent communication skills
April 19, 2010
• Tags: 6 months) Job in Genève 1207, Genève Switzerland, Regulatory Affairs Scientist (Fixed-term contract • Posted in: General