This is a great opportunity to join a pharmaceutical group which is enjoying significant growth both in Ireland/UK and internationally. The group of companies are proud of its expanding business which includes market leading brands across OTC and Prescription medicines. This role will suit someone who is fast paced and looking to work in an environment that is anything but mundane!
The company works with a trusted network of global partners to identify and introduce clinically proven products
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
Flexible and fast paced
8-10 years previous experience will be needed
Salary: €80,000.00-€90,000.00 per year
* O salário de referência é obtido com base em objetivos de salário para líderes de mercado de cada segmento de setor. Serve como orientação para ajudar os utilizadores Premium na avaliação de ofertas de emprego e na negociação de salários. O salário de referência não é indicado diretamente pela empresa e pode ser significativamente superior ou inferior.