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Novartis

Senior RA Associate

Dubbo, Australia

Summary

-Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. 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.

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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 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

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? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Division
Development

Business Unit
Pharmaceuticals

Location
Australia

Site
New South Wales (NSW)

Company / Legal Entity
AU04 (FCRS = AU004) AU Pharma Pty Ltd

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No

Client-provided location(s): New South Wales, Australia
Job ID: Novartis-391468BR
Employment Type: Full Time