Senior Regulatory Affairs Associate

29 Apr, 2020


Senior Regulatory Affairs Associate

Teva Pharmaceuticals
Sydney, Australia
Company Info
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Position Summary

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

Job Description
  • 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
Qualifications / Experience
  • 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
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Reports To

Senior Manager, Regulatory Affairs, ANZ

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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva’s global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
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Job posted: 2020-04-29