Job Opportunity: Regulatory Affairs Specialist
This is a great opportunity to join a pharmaceutical group that is experiencing significant growth in Ireland, the UK, and internationally. Our expanding business includes market-leading brands across over-the-counter (OTC) and prescription medicines.
This is a permanent role with excellent opportunities for growth and a competitive salary package.
About This Role
Due to continued growth, we are recruiting for a new position reporting to the Regulatory Affairs Manager.
Key Responsibilities:
* Ensure our products comply with all relevant regulations and standards.
* Execute Type IA, IB, and II Variations.
* Manage licence transfers.
* Review promotional material for medicinal products.
* Prepare Module 1 documentation for national applications.
* Participate in meetings with regulatory authorities.
* Handle regulatory aspects of internationalising products and applying for reclassification.
* Train and mentor junior team members on regulatory processes and compliance.
* Monitor and interpret regulatory trends relevant to the industry and keep the company informed.
Knowledge & Experience
* Be highly resilient and adaptable, able to work under pressure and within deadlines.
* Results-driven with a focus on completing tasks efficiently.
* Knowledge of MRP, DCP, and CP procedures.
* Medical devices knowledge is highly desirable.
* Excellent attention to detail and organisational skills.
* Able to work independently and take responsibility for actions.
* Essential 3-4 years of relevant experience.