Regulatory Affairs Associate
- Company
- i-Pharm Consulting
- Location
- Victoria, Australia
- Salary
- AUD80000.00 - AUD95000.00 per annum
- Posted
- Tuesday, 31 January 2023
- Closes
- Tuesday, 14 February 2023
- Ref
- BBBH28301
- Contact
- Rachel Louise
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Benefits:
- Impressive development potential and responsibilities as you take on sole responsibility of the regulatory affairs requirements
- Close knit team and competitive salary package
- Working in a fast paced, deadline focused environment and reporting directly to the QA Manager
Responsibilities
- Prepare and manage regulatory documents with the TGA
- Develop and coordinate all labelling activities and ensure they meet regulatory requirements
- Maintain current knowledge of relevant regulatory and legal changes and updating stakeholders as required.
- Provide regulatory input for projects and liaising with regulatory departments of sponsors
- Develop Evidence Packages and Tables
- Review and submit Registered and Listed Medicines on the ARTG
- Maintain regulatory compliance of all products
- Respond to and manage any regulatory affairs issues and customer enquiries
Requirements
- Minimum 2 years experience in a similar regulatory position
- Strong written and verbal communication skills, preferably with customer service experience
- Able to work autonomously and self manage your schedule
- Tertiary education in a relevant field