Regulatory Affairs Assistant

Summary about this job

Detail information about job Regulatory Affairs Assistant. Terms and conditions vacancy

• Dynamic manufacturer of complementary healthcare products
• SW Sydney location
• Permanent career opening. 

Working as part of the Technical team, the successful candidate will be responsible for the preparation of specifications, manufacturing and packaging documentation to meet all the required GMP and TGA regulatory standards. 

Responsibilities:

• Develop Specification and Regulatory documentation
• Develop internal and external customer Specifications
• Prepare master manufacturing and packaging Documents
• Assist with the development of regulatory policies and procedures
• Conduct material assessments to comply with quality standards
• Participate in the planning and process flow of products through manufacturing
• Provide technical/regulatory guidance and support to internal and external stakeholders

Criteria:

• A Bachelor of Science or equivalent in Chemistry
• At least 3 to 5  years’ experience working in the pharmaceutical sector
• Working knowledge and ability to interpret Australian code of GMP and TGA regulations
• Pharmaceutical formulation development
• Knowledge of national & international pharmaceutical regulatory requirements
• High level of attention to detail, initiative and strong work ethic
• Committed to innovation, able to manage time and projects with accuracy
• MRP and SAP skills highly advantageous
• Superior written and oral communication skills

Great package, great team environment.  Apply on line today or call Fiona on 02 9586 1747 to find out more. 

Contact Details: [email protected]