Regulatory Affairs Data Administrator
3 weeks ago
Turn precision into impact Bring your regulatory and data expertise to Australia's largest generic pharmaceutical company.
About DBG Health & Arrotex Pharmaceuticals
DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 1,500 dedicated professionals, we are committed to delivering affordable and innovative solutions that enhance the wellbeing of all people. Arrotex Pharmaceuticals is Australia's largest and most diversified pharmaceutical provider, offering the most extensive range of prescription products across the spectrum of therapeutic areas.
We are dedicated to delivering timely, sustainable, and affordable access to trusted medicines, reliable services, and innovative solutions that enhance the quality of life for all. Our values of Pioneering, Accountability, Collaboration, and Tenacity are the PACT our team members make to be our best every day and work together to deliver this vision and create a great place to work.
About The Role
As the Regulatory Affairs Data Administrator, you'll play a key role in ensuring the accuracy, compliance, and integrity of the regulatory data which underpins Arrotex's product portfolio. Working within the Scientific Affairs team, you'll manage product and manufacturer registration records in the Veeva Regulatory Information Management (RIM) system, support product lifecycle activities, and coordinate safety updates to meet TGA requirements.
This role is ideal for someone with regulatory knowledge and strong data administration skills who is eager to contribute to patient safety, compliance, and the delivery of affordable healthcare products.
Role & Responsibilities
- Maintain regulatory systems by keeping product and site records in Veeva RIM accurate, current, and compliant.
- Support product management through system lifecycle maintenance of submissions and regulatory approvals.
- Ensure compliance and accuracy via reconciliation of ARTG entries and maintain strong data integrity across all regulatory information.
- Assist in the management of safety updates and other regulatory administration activities, including management of TGA correspondence, notifications, invoicing queries, and financial tracking.
- Provide reporting and support via report generation, tracking key metrics, and working closely with Regulatory Affairs and other teams.
Skills & Experience
- Sound understanding of regulatory affairs processes and requirements for therapeutic goods.
- Strong data administration and record management skills, with attention to accuracy and compliance.
- Experience supporting a Regulatory Affairs / Scientific Affairs team in an administrative capacity.
- Familiarity with Regulatory Information Management (RIM) and/or electronic submission systems (e.g., eCTD).
- Prior experience with Veeva RIMS is highly regarded.
- Proficiency in business administration tasks, including document control and reporting.
- Strong team player with ability to collaborate effectively with stakeholders.
- Diploma (or higher) in a relevant scientific or business administration field.
Benefits & Perks
- Convenient head office location close to public transport, cafes and restaurants.
- Generous parental leave scheme.
- Ability to purchase additional leave.
- Explore the option of paying for your vehicle costs through novated leasing.
- Exclusive discounts on our consumer health, wellness and beauty products.
- Opportunity to grow your career across all divisions within DBG Health.
DBG Health is committed to fostering a workplace culture that is safe and accessible for all. We are an equal-opportunity employer and encourage applications regardless of cultural background, gender identity, sexual orientation, disability or neurodiversity.
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