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Job Summary
Regulatory Affairs Officer
Key Responsibilities
- Research and interpret global regulatory and legislative requirements, summarising them to meet business needs.
- Manage product and supplement registrations internationally by initiating, compiling, approving, and submitting necessary documents to relevant regulatory bodies.
- Research and summarise regulatory requirements for new territories.
- Initiate and execute Change Control processes for regulatory updates as required.
- Prepare and authorise declarations for Australian shipments.
- Ensure adherence to national and international legislation by reviewing standards against dossiers per alert notifications.
- Oversee the lifecycle of product registrations in line with legal and regulatory standards.
- Request product information or declarations from R&D, generate Safety Data Sheets (SDS) for finished goods, and file electronically.
- Implement regulatory actions as directed by senior management's risk evaluations.
- Review artwork to ensure global regulatory compliance based on brand specifications.
- Collaborate with cross-functional teams to ensure adherence to regulatory standards.
Qualifications & Experience
- Bachelor’s degree in Science or a related field.
- 2–3 years of relevant regulatory experience in a manufacturing environment.
- Experience in the cosmetic or pharmaceutical sector.
- Strong written and verbal communication skills.
- Excellent attention to detail and organisational abilities.
- Ability to manage multiple projects independently.
- Proficiency in computer applications.
O'Brien Recruitment
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