Regulatory Affairs Compliance Associate

3 days ago


Sydney, Australia Healthcare Professionals Group Full time

**Benefits**
- Work for a leading Pharmaceutical company
- Challenging Regulatory role with a collaborative team
- Part time position - competitive salary package on offer + benefits

**About the company**
Our client is a global pharmaceutical company who is committed to improving and extending people's lives through medical science and digital innovation.

**About the opportunity**
As a Regulatory Affairs Compliance Associate, you will be responsible for ensuring regulatory compliance in accordance with our client's processes, procedures, and systems, as well as relevant Australian and New Zealand legislation and guidelines. You will handle regulatory information, manage mailboxes, and oversee the change control process from a regulatory affairs perspective. You will work collaboratively with various stakeholders to ensure that our client maintains its high standards of quality and compliance.This is a part time position with an opportunity to WFH.

**Duties**
- Handle regulatory information using our client's Regulatory Information Management tools.
- Ensure key operational trackers are kept up-to-date and that information is entered with consistency by RA Associates
- Manage department’s mailboxes and triage incoming data packages
- Validate pre and post approval activities to ensure compliance with health authority requirements are met
- Oversee change control process from Regulatory Affairs perspective, collaborating with QA and Supply Chain
- Perform and respond to Global Regulatory Compliance Checks and liaising with local QA and Supply Chain on resolving supply issues
- Conduct risk analyses, develop effective procedures and tracking tools
- Provide assistance and support in preparation for and during the course of internal and external audits and inspections of RA operations

**Skills and Experience**
- Tertiary qualified - Pharmacy or Science
- Relevant postgraduate qualification would be considered an advantage
- Experience working within the Pharmaceutical Industry with a strong understanding of compliance standards in Regulatory Affairs
- Strong understanding of quality systems and Australian and New Zealand regulations
- A thorough working understanding of regulatory compliance
- Strong communication and ability to work cross functionally

**Culture**
Our client is committed to fostering a diverse, equitable, and inclusive environment that inspires new ways of working. Their culture is underpinned by integrity, curiosity, and flexibility.

**How to Apply**

**Job details**:

- Location
- Sydney
- Salary
- Competitive
- Job Type
- Part Time
- Ref
- BH-39822
- Contact
- Gemma Staddon
- Contact phone
- +612 8877 8776
- Posted
- 26 minutes ago



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