Job Opportunity: Regulatory Affairs Specialist
This is a great opportunity to join a pharmaceutical group experiencing significant growth in Ireland, the UK, and internationally. Our expanding business includes market-leading brands across OTC and Prescription medicines. This is a permanent role with excellent opportunities for growth and a competitive salary package.
Due to continued growth, we are recruiting for a new position reporting to the Regulatory Affairs Manager.
Key Responsibilities:
1. Ensuring the company’s products comply with all relevant regulations and standards.
2. Knowledge and execution of Type IA, IB, and II Variations.
3. Managing licence transfers.
4. Reviewing promotional material for medicinal products.
5. Preparing Module 1 documentation for national applications.
6. Participating in meetings with regulatory authorities.
7. Handling regulatory aspects of internationalising products and applying for reclassification.
8. Training and mentoring junior team members on regulatory processes and compliance.
9. Monitoring and interpreting regulatory trends relevant to the industry and keeping the company informed.
Knowledge & Experience:
* 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.
* Knowledge of medical devices is highly desirable.
* Excellent attention to detail and organizational skills.
* Ability to work independently and take responsibility for actions.
* 3-4 years of relevant experience is essential.
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