When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Regulatory Affairs expertise with medicinal products for changes with impact on Product Information - Safety / Labelling changes, including CCDS creation or updates
Experience:
1. Regulatory Affairs Experience – Minimum 5 years - EU/UK/CH/AU/NZ:
- Safety Labelling changes with impact on Product Information and management of AW updates from an RA perspective
- CCDS creation or updates prior experience preferable
- Change control assessments
- Experience working on Centralized products is a plus
2. Veeva RIMS Knowledge.
3. Knowledge in using TVT Tool is a plus.
Regulatory Affairs expertise with medicinal products for changes with impact on Product Information - Safety / Labelling changes, including CCDS creation or updates
Premier Consulting
Lifelancer
Monks
FUGA
Cochlear