Regulatory Affairs Expert
5 days ago
We are seeking a highly skilled Regulatory Affairs Officer to join our team at Acme Generics. As a key member of our regulatory department, you will be responsible for ensuring compliance with regulatory guidelines and requirements for the registration of pharmaceutical products.
Job Summary:The successful candidate will have experience in compilation, preparation, and review of dossiers in CTD, ACTD formats, and country-specific regulations. You will work closely with our production, quality assurance, quality control, packaging, and research and development teams to ensure seamless technical data exchange.
Responsibilities:- Compilation, preparation, and review of dossiers in CTD, ACTD formats, and country-specific regulations
- Active coordination with cross-functional teams for technical data requirements
- Knowledge/exposure of ICH Guidelines (QSEM) required for Common Technical Document (CTD) registration of pharmaceuticals
- Preparation and review of SmPC, Package Insert, and labeling information
- Online application filing for dossier submission in the US
- Handling client and MOH queries as per received guidelines
In this role, you will play a critical part in ensuring that our products meet the highest standards of quality and regulatory compliance. If you have a strong background in regulatory affairs and are passionate about delivering high-quality results, we encourage you to apply for this exciting opportunity.
About Us:Acme Generics is a leading provider of generic pharmaceuticals, committed to delivering innovative solutions to meet the evolving needs of healthcare professionals and patients worldwide. We are driven by our mission to improve patient outcomes through the development and commercialization of high-quality medicines.
Salary Estimate:We offer an attractive salary package commensurate with your experience and qualifications, including a base salary of approximately $80,000-$100,000 per year, depending on location and performance.
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