Purpose of the Position/ Role Summary

Reporting to the Regulatory Affairs Team Leader, the Regulatory Affairs Associate Level I is responsible for the day to day Regulatory Affairs activities within the Regulatory Affairs Department.

This is a full-time, permanent position operating on a hybrid working model (with a combination of office-based and remote working, aligned to business needs).

The salary range for this role is €35,000–€40,000 per annum, depending on experience.

Key Role Specific Requirements

•    Prepare, compile, and submit license renewal applications in accordance with strict deadlines, and manage application through to completion.
•    Prepare, compile, and submit variation applications to support changes to authorised details and manage applications through to completion for national, mutual recognition, decentralised or centralised procedures.
•    Assist to update, prepare, compile, and submit new product applications through national, mutual recognition, decentralised or centralised procedures.
•    Collect, collate, and evaluate scientific data, and present the information in an organised format.
•    Preparation of responses to queries from regulatory agencies on new and existing products in conjunction with relevant personnel.
•    Liaise with Regulatory Authorities and external customers/distributors.
•    Work closely with all departments, providing regulatory support for the operations and control of the facility.
•    Inform relevant departments of changes in registered details and update internal data bases with changes and the status of on-going tasks.
•    Keep up to date on information on regulatory websites as regards new guidelines, fees and application documents and inform all relevant stakeholders, where relevant.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve. 

Other Requirements

Essential: 
•    Minimum 3rd level Science degree.
•    1-2 years’ Regulatory Affairs experience within the Pharmaceutical or related industry.
•    Good understanding of Pharmaceutical controlled documentation practices.
•    Proficient in the use of MS Office tools

Desirable:
•    Post-graduate education in Pharmaceutical Technology and Regulatory Affairs desirable.  
•    Experience in Pharmaceutical license variation requirements.