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Senior Regulatory Affairs Associate (part time)

Date: Jun 8, 2021

Location: New Zealand, NZ, 1010

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader, 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 specialty and generic 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!

Job Description

This is a hands-on role and you will be responsible for preparing regulatory submissions and providing strategic regulatory advice and operational support, for in market products and portfolio expansion. A key focus will be on our growing pipeline of generics, across Australia and New Zealand. Please note that this role will be based in our Sydney office.

 

Key responsibilities of this role include:

 

  • Prepare submissions and product information changes to align with government legislation/ corporate requirements and/or brand strategy.
  • Prepare new product marketing applications and co-ordinate company responses during the review process.
  • 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.
  • Maintain dossier compliance through change control assessment, provision of regulatory advice and submission of post-approval changes

Qualifications

  • Degree preferred in any the following disciplines: Biological sciences, pharmacy, nursing, life sciences
  • 5+ year’s regulatory affairs experience in the pharmaceutical industry in Australia or New Zealand.
  • Previous experience with generic applications.
  • Excellent communication skills with written and verbal fluency in English.
  • Ability to work independently with a high attention to detail.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

In process of validation

Already Working @TEVA?

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

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

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.