Senior RA/QA Associate
Core
Senior Regulatory Professional managing local and international CMOs, ensuring compliance with regulatory requirements, developing strategies, and preparing documentation for regulatory dossiers and license renewals.
Role type
Senior Regulatory Affairs and Quality Associate
Builds
Regulatory compliance strategies and documentation for pharmaceutical products
Domain
Pharmaceutical industry, Regulatory Affairs, Quality Assurance
Deliverable
client delivery
Required skills
Auditing (Australia GMP, ISO 13485), Regulatory planning, Submission preparation, Project planning, Knowledge of TGA and MedSafe regulations, Review of manufacturing and quality documentation (Change Controls, CAPA, SOP), Product labelling compliance
Preferred skills
None stated
Technologies
None stated
Responsibilities
Management and leadership of branded products ensuring compliance with internal and external regulatory requirements, Managing on-going compliance requirements and developing regulatory strategies, Preparing documentation for regulatory dossiers, drug master files, licence renewals, Performing ISO 13485 and GMP audits on CMOs, Review and approve all product labelling for compliance with relevant regulations
Seniority
Senior, hands-on IC
