Job details
- Location
- Melbourne
- Salary
- $61.85 per hour
- Job Type
- Temporary
- Ref
- BH-41462
- Contact
- Rohan Lallbeeharry
- Posted
- 13 days ago
Job details
- Location
- Melbourne
- Salary
- $61.85 per hour
- Job Type
- Temporary
- Ref
- BH-41462
- Contact
- Rohan Lallbeeharry
- Posted
- 13 days ago
Benefits
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
Skills and Experience
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.
- 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.
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