An exciting opportunity has risen for a Regulatory Affairs Specialist to join a new and expanding facility based in Dublin. This is an opportune time to join this company as it is at an exciting phase of their company's growth.
The post holder will be responsible for performing regulatory activities for generic products to ensure compliance with the EMA.
Key Responsibilities
- Perform Regulatory Affairs activities ensuring compliance with applicable regulations and requirements.
- CTD preparation
- Being in contact with CDMO for product development and project management
- Being in contact with authorities in the EU to file the dossier.
- Maintain a good understanding of existing and emerging pharmaceutical regulations
- Liaise effectively with internal departments and external suppliers to support the new product development, document preparation and launch
- Operate within the Quality Management System across all regulatory related activities
- Preparation of monthly metrics and reports
- Participate in regular team and group meetings ensuring to keep the management team updated on issues and actions which impact the business
- Support cross-training opportunities and skills
- Provide day-to-day department support activities as necessary to aid completion of project deliverables.
Requirements
- Educated to degree level or higher in a scientific discipline.
- 2+ years regulated pharmaceutical experience in a Regulatory Affairs role.
- Working knowledge of European and international regulatory requirements, including EMA regulations, ICH guidelines, and other relevant regulations.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
