I'm delighted to be working an exciting new role with one of our Dublin based clients. In this role, you will manage 1000's of products across a number of different countries. This company is enjoying significant growth across Ireland/UK and internationally. Our group of companies are proud of our expanding business which includes market leading brands across OTC and Prescription medicines. Permanent role, with excellent salary. This role is open to hybrid or remote working. Candidates may be based in Ireland, the UK or Europe. Please note - all candidates must have existing right to work in Ireland, UK or EU citizen.
Key responsibilities:
- Develop and implement regulatory strategies to support product development and lifecycle management
- Manage a team of Regulatory Affairs Officers to ensure the Company’s products comply with all relevant regulations and standards
- Efficiently integrate all new portfolio acquisitions in multiple markets
- Lead projects on identifying any gaps in dossiers and devising plan to resolve these gaps.
- Lead meetings with Regulatory Authorities
- Lead regulatory aspects of internationalising products and applying for reclassification of products
- Monitor and interpret regulatory trends and changes relevant to the industry and pro-actively keep the Company appraised of these.
- Collaborate cross functionally with Quality and Commercial/Marketing teams to achieve Company objectives
Knowledge & Experience:
- Highly resilient and adaptable, able to work under pressure and within time constraints
- Drives results on a timely basis and sees things through to conclusion
- Strong knowledge of global regulatory frameworks
- Knowledge of MRP, DCP, CP
- Knowledge of medical devices highly desirable
- Excellent attention to detail and organisational skills
- Capable of working on own initiative and taking responsibility for course of action
- 8-10 years previous experience essential
