Regulatory Affairs Officer

Benefits

• Must have unrestricted work rights for 12 months
• Working within a global team
• Monday to Friday only

About the company
Work within a large global Biotechnology company that boasts a good company culture that is always expanding.

About the opportunity
The Regulatory Affairs Officer will provide technical and administrative Regulatory Affairs support to the Global Regulatory Affairs function.

Duties

• Supporting the wider regulatory Affairs team in APAC not just the current team
• Preparation, compilation and submission of Marketing Application and variations for new or life cycle products
• Prepare applications such as export listings, GMP licence/certificates, and Certified Products Details
• Help prepare the regulatory component of the life cycle documents such as PSURs, annual reports
• Prepare dossier preparation check/tracking lists including requesting missing documents and monitoring deadlines
• Help prepare and amend the CMC dossier narratives for the Comprehensive CTDs (except for preclinical, clinical and regional parts) including the Plasma Master Files (PMFs) and clinical trial applications/notifications
• Help review guidelines and coordinate/prepare comments
• Work with managers and specialists in preparing Module 1 documentation, QC checks and application submissions
• Data entry and maintenance in/of regulatory systems and to provide outputs for eg audit requests
• Work with relevant product managers/scientists to prepare SOP’s/work instructions or check/tracking lists
• Work with the team leads or delegate to monitor the metrics/statistics, reports etc. for presentation purposes
• Work with managers/team leads to monitor training requirements and be the interface with training departments

Skills and Experience

• Must hold a Bachelor of Science degree or related qualification
• Must have at least one year of tertiary science or proven regulatory experience
• Function-related training in Regulatory Affairs
• Flexibility to work in a global regulatory cross-cultural work environment
• Team player with a demonstrated ability to develop constructive and effective relationships
• Awareness of regulatory affairs
• Ability to Initiate or execute improvement initiatives

Culture
Although a large, global company, they are able to provide a family-like culture and prides itself in improving the lives of others.

Why this opportunity is right for you
This is a Full-time 12-month replacement contract based in Melbourne.

How to Apply
Click apply or contact Rohan Lallbeehary, Senior Recruitment Consultant on 03 9938 7115 for a confidential discussion.