Regulatory Affairs Associate- Labelling

Regulatory Affairs expertise with medicinal products for changes with impact on Product Information - Safety / Labelling changes, including CCDS creation or updates

Experience:

1. 3-5 yrs of Regulatory Affairs experience in 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.