Share this Job

Senior Regulatory Affairs Associate

Date: Jun 22, 2022

Location: New Zealand, NZ, 1541

Company: Teva Pharmaceuticals

The Company

 

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!

The Position

 

As Senior Regulatory Affairs Associate, you will co-ordinate and prepare regulatory submissions, across a broad portfolio of products  This will involve working closely with cross functional brand teams, providing regulatory direction and advice, to facilitate our growth plans. In this role, you will be given the opportunity to provide your regulatory inputs in portfolio selection and supply related matters.

 

The successful candidate will be working in our NZ Office alongside a very experienced Regulatory Affairs Manager who heads up the ANZ RA team.  This is a hands on role within a collaborative and supportive ANZ regulatory team.

Key Responsibilities

 

  • Co-ordination and preparation of regulatory submissions, across a broad portfolio, inclusive of specialty & generic medicines, in AU & NZ.
  • Provision of strategic regulatory advice and operational regulatory support to cross functional brand teams, to facilitate our growth plans.
  • 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.

The Successful Candidate

 

  • A Bachelor’s degree preferred in any the following disciplines : biological sciences, pharmacy, nursing, life sciences

 

  • 3+ year’s regulatory experience in the New Zealand pharmaceutical industry
  • Experience with registration of prescription medicines would be highly regarded
  • Working knowledge of Australian and New Zealand regulatory approval processes
  • Good verbal & written skills, with a high attention to detail
  • Self-motivated with a sense of urgency
  • Ability to work independently & adapt to change
  • Comfortable in working in a highly networked environment

To Apply

 

Please submit your CV and a Cover Letter.

Please note that only shortlisted candidates will be contacted.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Senior Manager, Regulatory Affairs, ANZ

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.