Senior Regulatory Affairs Associate
Posted on :
31-07-2024
Employer Active
1 Vacancy
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Job Description
- What You’ll Do
This role is an opportunity for an experienced pharmaceutical regulatory affairs professional keen to move into a global organisation with a strong pipeline in Oncology, Cardiovascular, Immune Therapies and Respiratory.
As a Senior Regulatory Affairs Associate you will provide regulatory input to the development of business strategic and tactical plans. Deliver effective and commercially advantageous regulatory plans for product submissions, with the aim of attaining an optimum label and earliest commercial launch.
Essential For The Role
- Science related Tertiary qualifications
- Experience in a (Senior) Regulatory Affairs role from within the pharmaceutical industry in Australia/New Zealand
- Experience preparing category 1 applications
- Working relationships with the TGA and/or Medsafe and other relevant government agencies
- Demonstrated successes in building strong external and internal relationships through effective communication, influencing and collaborative networking skills
- Strong attention to detail, resilience and an ability to bring innovative ideas to problem solving
- Leadership skills including experience in leading cross-functional projects or teams
- Desirable for the role
- An understanding of biological medicines such as monoclonal antibodies
- New chemical entity/new biological entity application/submission experience preferable
Employment Type
Full-time
Department / Functional Area
Key Skills
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