Regulatory Affairs Specialist fast growing young pharma Dublin
- Are you looking to join a young, fast growing, highly ambitious young pharmaceutical company?
- Rapid growth in a small business requires individuals who possess a natural `can do `mentality, who will deal effectively with new challenges and where no two days are the same!
The Company is a growth oriented, investment backed organization, with management and staff taking a ?can-do? approach to all day to day activities and projects. In this permanent based newly created role you will have a ?hands-on? approach, strong attention to detail, judgement and decision making, planning and organising skills, as well as the ability to communicate effectively both verbal and written.
- This newly-created appointment will be responsible for co-ordinating registration and CMC regulatory support for commercial and development projects.
- Will ensure that all new licence and variation applications are planned, tracked and obtained in a timely manner in accordance with various FDA submission procedures.
- Activities, including planning, writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, NDAs, BLAs, meeting requests, and briefing documents).
- Coordinate the preparation and timely submission of responses to FDA with US based Regulatory Agent. Manage timelines to ensure approvals are timely and development objectives are met.
- Manage US commercial license maintenance
- Ensure continued regulatory compliance of products though change control procedure.
- Ensure all operations are fully compliant with licence details and updated in accordance with relevant guidelines and directives.
- Ensure up to date files are maintained for all licensed products manufactured and/or released in manufacturing.
- Review and approval of all new and revised master batch documentation, QC specifications and packaging work orders in line with licence details and relevant SOPs.
- Identification, compilation and approval of Regulatory SOP?s.
- Assist in the preparation, review and approval of new artwork.
- Monitor EU and US CMC regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
Bachelor of Science Degree qualification a scientific discipline.
- 3+ years? experience in a pharmaceutical industry.
- Ideal candidate will have experience in submissions to notified body / regulators (FDA, HPRA, & EU Bodies) for product approval. R.P status a distinct advantage.
- EU submission experience will be an advantage, but not essential.
- Ability to work well both on own initiative and across all levels, both internally and externally.
- Ideally candidates with have strong organization and communication skills, both verbally and in writing.
- Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.