Job Opportunity: Regulatory Affairs Specialist
This is an exceptional opportunity to contribute to the growth of a leading pharmaceutical group with significant presence in Ireland, the UK, and internationally.
The company’s expanding business includes market-leading brands across Over-the-Counter (OTC) and Prescription medicines. This is a permanent role with excellent prospects for professional development and a competitive remuneration package.
Main Responsibilities:
1. To ensure that the company’s products comply with all relevant regulations and standards.
2. Familiarity and execution of Type IA, IB, and II Variations.
3. Licence transfers management.
5. Participation in meetings with regulatory authorities.
6. Handling regulatory aspects of internationalising products and applying for reclassification.
7. Training and mentoring junior team members on regulatory processes and compliance.
8. Maintaining awareness 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 meet deadlines.
* Results-driven with a focus on efficient task completion.
* Familiarity with MRP, DCP, and CP procedures.
* Knowledge of medical devices is highly desirable.
* Excellent attention to detail and organisational skills.
* Ability to work independently and take responsibility for actions.
* At least 3-4 years of relevant experience is essential.