**Job Overview:**
We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring all activities associated with the manufacture and testing of medicinal products are conducted in accordance with the principles of Good Manufacturing Practice (GMP).
**Key Responsibilities:**
* Ensure Starting Materials Comply: Validate that starting materials used comply with requirements, supply chains are known, and audits have been carried out.
* Validate Manufacturing Processes and Testing Methods: Ensure manufacturing processes and testing methods meet marketing authorization requirements.
* Assess and Complete Changes: Assess changes accordingly and ensure they meet product registration and manufacturer's license requirements.
* Test Imported Products: Test imported products within the EU/EEA or according to Mutual Recognition Agreements.
**Requirements and Qualifications:**
To be considered for this role, you must have a degree in a scientific discipline and at least 5 years of experience in the pharmaceutical industry. You should also have attained Qualified Person status and be able to demonstrate continuous professional development.
**Key Skills and Experience:**
* Quality Management System Development: Experience in developing and implementing Quality Management Systems.
* Regulatory Agency Inspection Hosting: Proven ability to host regulatory agency inspections.
* Internal and External Quality Audits: Experience in conducting internal and external quality audits.
* Training in GMP Principles: Training in GMP principles and regulations.
* Experience with IMPs and Sterile/Biologics Products: Experience working with Investigational Medicinal Products (IMPs) and sterile/biologics products.