Regulatory Affairs Officer

2 months ago

Melbourne, Australia Healthcare Professionals Group Full time

**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
- 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 review guidelines and coordinate/prepare comments
- 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**

**Job details**:

- Location
- Melbourne
- Salary
- $61.85 per hour
- Job Type
- Temporary
- Ref
- BH-41462
- Contact
- Rohan Lallbeeharry
- Posted
- about 2 hours ago

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