AddressAbout the Role
Internal Role Title: Senior Regulatory Affairs Associate
Location: Sydney, Australia #LI-Hybrid
About the Role:
We bring life-saving and life-changing medicines to patients by determining the efficient regulatory pathway to accelerate the approval process whilst ensuring we achieve the broadest label vital so that as many patients can access our treatments. We do this by collaborating closely with our global colleagues, local brand teams and external stakeholders.
We are a highly experienced team that is results oriented, continues to learn, leverages off each other's experiences, and we look for opportunities to do things differently. Multi-tasking is a necessity as well as focus because we are in a growth phase. No two days are alike.
Key Responsibilities :-
- 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
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Essential Requirements:-
- 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.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
