My client is a multinational pharmaceutical company which holds a vast product portfolio that is distributed at a global scale. You will be a part of their Regulatory Affairs team to support the timely registration of new chemical entities, new dosage forms and new indications, along with ensuring that current registrations are maintained.
Your key responsibilities will be:
- Prepare, compile, and submit regulatory applications to TGA and Medsafe.
- Manage and ensure regulatory maintenance of existing product registrations to the TGA and Medsafe.
- Liaise with local and international stakeholders and provide strategic advice on potential regulatory concerns and new regulatory development.
- Ensure compliance with all systems and processes.
- Minimum 4 years’ experience as a regulatory affairs associate in a pharmaceutical or medical device company.
- Bachelor’s degree or equivalent in Science, Chemistry or Pharmacy.
- Strong interpersonal skills and ability to liaise with multiple departments within the company.
- Excellent communication skills and proven experience working collaboratively within a team environment.