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.
In addition, responsibilities 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.
- Assist in the liaison with health authorities for regulatory activities as needed.
- Make use of document management systems for eCTD submission.
- Ensure the maintenance and revision requirements of existing regulatory files are addressed and in line with actual practise, methods and procedures of CMO's and service providers.
- Provide change management for amendments and updates to existing regulatory files and ensure utilizing the appropriate submission procedures.
- Ensure preparation and sharing of regulatory documents (open part of the DMF / Tech Pack) to address customer needs.
- Ensure regulatory documentation for health authorities and customers is tracked appropriately.
- To identify compliance risks and escalate compliance risks to management when necessary.
You will have a minimum of 2 years' experience in a similar role. A third level qualification in science is required.
To learn more about this role apply online or contact Paul Wheatley on +353873449559 for a confidential discussion.