Senior Regulatory Affairs Associate
Novartis
- Sydney, NSW
- Permanent
- Full-time
- Submit NCE/NBE and line extensions to AU and NZ health authorities as per business alignment
- Gap analysis of submission packages and develop the submission strategy which may include HA meetings
- Maintain allocated products for example CMC and packaging changes which includes forward planning to avoid shortages
- Minor PI updates (SRR or Type J)
- Prioritise tasks based on business criticality.
- Actively participate in brand team meetings and review promotional material
- Contribute to consultations, internal processes and projects
- Communicate optimally (written and verbal) to a range of partners
- BSc or equivalent experience preferably biological sciences, chemistry or pharmacy
- 3+ years working as a Senior Associate
- Broad AU regulatory experience with multiple Cat 1 experience.