Senior Regulatory Affairs Associate
vor 2 Wochen
Internal Role Title: Senior Regulatory Affairs Associate
Location: Sydney, Australia #LI-Hybrid
We bring life-saving and life-changing medicines to patients by determining the optimal regulatory pathway to accelerate the approval process whilst ensuring we achieve the broadest label necessary so that as many patients can access our treatments.
We do this by collaborating closely with Novartis global colleagues, our local brand teams and external health authorities.
We are a highly experienced team that is goal orientated, continues to learn, leverages off each other's experiences and we look for opportunities to do things differently.
About the Role 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 meeting Maintain allocated products for example CMC and packaging changes which includes forward planning to avoid shortages Minor PI updates (SRR or Type J) Prioritize tasks based on business criticality.
Actively participate in brand team meetings and review promotional material Contribute to consultations, internal processes and projects.
Communicate effectively (written and verbal) to a range of stakeholders Demonstrate and encourage behaviors that promote a positive, collaborative team culture.
Provide constructive feedback and mentoring to team members to help build capabilities.
Qualifications:
Science, Pharmacy, Medicine or other relevant degree.
Postgraduate qualifications would be an advantage Senior RA associate with proven track record of innovation, technical competence and successful business outcomes or 6+ years' experience as an RA associate.
Australian experience preferred although RA experience in US, EU or Canada would also be considered Broad AU regulatory experience dealing with and solving a broad range of complex business and/or regulatory issues.
Will consider candidates with prior regulatory experience working in following jurisdictions: Singapore, Canada, US, EU but relocation is not supported.
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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