Senior Regulatory Affairs Associate
Co-ordination and preparation of regulatory submissions. Provision of strategic regulatory advice and operational regulatory support to cross functional brand teams.
Provision of regulatory input/contribution in portfolio selection and supply related matters
- Prepare submissions and product information changes to align with government legislation/ corporate requirements and/or brand strategy, with cost-efficiency and according to budgetary requirements.
- Prepare new product marketing applications and co-ordinate company responses during the review process.
- Product rescheduling submissions for approval.
- Co-ordinate preparation and revision of product packaging artwork
- Complete gap analysis on registration dossiers to ensure they comply with government regulations prior to submission.
- Provide regulatory affairs support for clinical research activities, as required
- Utilise and maintain Teva’s regulatory systems and records in accordance with global and local guidelines
- Any other duties as assigned by management
- Degree preferred in any the following disciplines: Biological sciences, pharmacy, nursing, life sciences
- 5+ year’s pharmaceutical industry experience in Australia.
- Previous experience with generic applications, eCTD submissions and the New Zealand regulatory environment would be highly regarded.
- Good verbal and written communicaiton skills
- High attention to detail
- Self-motivated with a sense of urgency
- Ability to work independently and adapt to changing situations
- Comfortable in working in a highly networked environment
Senior Manager, Regulatory Affairs, ANZ
If you are a current Teva employee, please apply using the internal career site available on “Employee Central”. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
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Job posted: 2020-04-29