Our client is a pharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. The organisational goal is to improve the care of patients living with life-threatening diseases around the world. They are now seeking a Regulatory Affairs Specialist to join their team in Cork. This role offers the opportunity to work from home.
Duties and responsibilities of the Regulatory Affairs Specialist will include:
- Assist in the creation, review and submission of regulatory documents to authorities for new API's and Products (USDMF/ASMF/CEP/J-DMF/other markets. Compile QOS, CTD Module 2, Module 3, other regulatory files, etc.).
- Collect reports and documentation as well as coordinate the content and format of submissions according to requirements by the health authorities (EU/US/Japan/Asia/Rest of World).
- Coordinate requirements and collaborate with QA/QC/Production/Development Departments of CMOs and Service providers.
- Gain knowledge of directives and guidelines published by ICH, US-FDA, EDQM and similar. Maintain current knowledge of relevant international guidance documents, laws and regulations, as well as proposed and finalized rules affecting APIs.
- Assist in the coordination and preparation of adequate responses to questions and inquiries from health authorities with stipulated timelines.
You will have skills and experience in the following:
- Degree in Science or a related discipline
- 3+ years relevant experience in pharmaceutical/biopharmaceutical
To learn more about this role apply online or contact Laura Gallagher on 00353 876383699 for a confidential discussion.