Senior / Regulatory Affairs Associate: Part-time (BBBH34708) North Shore, Australia
|Salary:||Super + Benefits|
About the company
An established pharmaceutical company who focus on innovative pharmaceuticals that improve health and wellbeing worldwide. They take involvement in research, development, manufacturing, and marketing of their products expanding into international markets and exploring new and niche therapy areas.
About the opportunity
You will support the RA/QA Manager across all regulatory and quality aspects of the product portfolio, ensuring compliance with the TGA, Medsafe, GMP, pharmaceutical and manufacturing standards. You will use your technical expertise to coordinate and submit licenses and authorizations to support optimal timelines for new/modified product launches.
Part-time: 3 or 4 days per week. 12 month contract initially, potential to be become a permanent employee.
The focus of this role will be in regulatory affairs but the ideal candidate will have exposure to both regulatory affairs and quality assurance in an innovative pharmaceutical company.
- Ensure the registration and compliance of locally marketed products through the lifecycle
- Prepare regulatory submissions for new products and product information updates for ANZ
- Provide cross functional support with regulatory input and regulatory strategy for new product launches
- Liaise with regulatory bodies such as TGA, Med Safe and other international regulatory bodies
- Review of artwork and promotional material and make recommendations
- Manage the complaints process to ensure timely recording in line with company and regulatory policies
- Liaise with local teams to ensure shipments and special access schemes are managed efficiently
- Ensure all supply chain and distribution is adherent with GMP and SOP’s from a quality perspective
Skills and Experience
- Tertiary qualification in a scientific discipline
- Minimum 5 years’ experience within pharmaceuticals across Regulatory Affairs and Quality Assurance
- Proven experience liaising with TGA and Med Safe and knowledge of regulatory framework for pharmaceuticals
- Independent experience managing a Cat 1 submission is preferred
- Experience working with all aspects of commercial quality system
- Experience working with a range of therapy areas
- Effective communicator and the ability to liaise with stakeholders at all levels
How to Apply
Click apply or contact Joanna Murphy, Recruitment Consultant, on 02 8877 8718 for a confidential discussion.