Senior Regulatory Affairs Associate

Date: Aug 9, 2024

Location:

Sydney, Australia, 2113

Company: Teva Pharmaceuticals

Job Id: 56891

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

We are seeking a highly skilled and experienced Senior Regulatory Affairs Associate to join our regulatory affairs team.

In this role, you will prepare and execute regulatory submission plans and implement the agreed regulatory strategy to register and maintain products across a range of therapeutic areas, covering both Australia and New Zealand.

This role requires strong attention to detail, excellent communication skills, and a deep understanding of regulatory guidelines and processes within the pharmaceutical industry.

How you’ll spend your day

• Prepare and submit regulatory dossiers to health authorities for new product approvals and maintenance variations.

• Ensure compliance with all relevant regulations, guidelines, and company policies.

• Monitor and analyse regulatory changes and trends to ensure company compliance.

• Assist in the development and implementation of regulatory strategies for new and existing products.

• Maintain up-to-date knowledge of global regulatory requirements and ensure that company practices align with these standards.

• Review and approve labelling, promotional materials, and other product-related documentation for regulatory compliance.

Your experience and qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Biological sciences, or nursing.

• Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry with hands on experience with NCE and complex generic submissions.

• Experience preparing category 1 applications.

• Proven track record of successful regulatory submissions and product approvals.

• Working relationships with the TGA and/or Medsafe and other relevant government agencies.

• Strong communication and interpersonal skills.

• Strong attention to detail, resilience, and an ability to bring innovative ideas to problem solving.

• Ability to work independently and collaboratively in a fast-paced, dynamic environment.

Enjoy a more rewarding choice

• Generous leave, health, and wellbeing benefits.

• Commitment to ongoing personal & professional growth via a blend of learning opportunities.

• Opportunity to join a leading global organisation with a network of 37,000 employees operating in 60 markets, with 25 R&D sites.

Make a difference with Teva Pharmaceuticals

Please submit your CV and a cover letter responding to the selection criteria outlining relative keys skills and experience in relation to this role.

Please note that only shortlisted candidates will be contacted.

Reports To

Regulatory Affairs Manager 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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

EOE including disability/veteran