PAREXEL values passion, global perspective and expertise and we are in the process of recruiting full time, permanent Senior Regulatory Affairs Associate (CMC Writer) to join our PAREXEL Consulting team in Bucharest.
Main responsibilities include:
• Generate/writing CMC documentation (Module 3, and Module 2 experts summaries).
• Provide operational support to prepare submissions
• Strict adherence to timelines (both internal and HA deadlines).
Qualifications• Several years of performing the above tasks on a global level
• Knowledge and understanding of manufacturing process, in process control, analytical process, stability studies
• Good project Management skills
• Proactive approach and excellent communication skills
• Fluent English and Romanian
If you feel you have suitable experience, we welcome you to apply today and kickstart your journey with Parexel!