REGULATORY AFFAIRS SPECIALIST
2013-10-22
The goal of Regulatory Affairs Specialist is to coordinate, develop and deliver RA services for identified products.
Job responsibilities:
- Preparing high quality documentation for all regulatory submissions without supervision (based on agreed RA strategy plan)
- Liaising with relevant departments to ensure regulatory requirements for these submissions are met
- To provide regulatory advice and support to other areas of the company
- To manage life cycle maintenance for designated product portfolio including management of variations
- Proactively communicating with regulatory authorities
Requirements:
- University Degree (medical, pharmaceutical, hard sciences)
- Min. 3 years in Regulatory Affairs
- Understanding of the EU regulatory requirements for submissions via national, DCP and CP routes
- Advanced PC skills (MS Office)
- Excellent analytical and documentation skills
- Fluency in spoken and written English
Contact:
Veronika Kartariková
mobile: +420 602 322 490
e-mail: veronika_kartarikova@drill.cz
