This leading pharmaceutical group has operations in South Dublin and the UK and are focussed on the development and commercialisation of speciality products and other high-value niche products. Due to growth, there is an opportunity for an experienced Regulatory Affairs professional to join their team on an initial 12-month fixed-term contract. The role is a Senior RA Officer.
Reporting into the AD of Reg Affairs, some of the role responsibilities will include:
- Review current registration dossier for all marketed products to identify and record dossier completeness, formatting issues, compliance with guidelines/legislation, on-going regulatory issues (pending variations) and outstanding regulatory commitments.
- Ensure timely preparation and compilation of registration dossier for assigned projects in accordance with EU and international standards.
- Managing and coordinating various regulatory activities throughout the life cycle of the project/product.
- Maintain assigned products' Marketing Authorisations via timely variations and renewals submissions and their approvals.
- Regulatory assessment on all change controls and other documentation, ie. stability protocols, specifications, product quality reviews and related reports to ensure compliance with current registered dossiers and commitments made to agencies.
- Bachelor's Degree in Pharmaceutical discipline with 5+ years of experience in quality and regulatory teams within cosmetic and pharmaceutical manufacturing facilities.
- Attention to detail and quality of documentation.
- Good interpersonal skills.
- Ability to work independently with direction.
- Proven ability to work effectively in a team environment.
- Ability to handle multiple projects.
- Excellent career and professional development opportunities.
- Competitive salary.
- Flexible working hours and work from home options.
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.