This is a great opportunity to join a pharmaceutical group that is experiencing significant growth both in Ireland/UK and internationally. Our group of companies proudly features expanding business operations, including market-leading brands across OTC and Prescription medicines.Due to this continued growth, we are now recruiting an additional Regulatory Affairs Manager.ResponsibilitiesDevelop 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 to identify gaps in dossiers and devise plans to resolve these gaps.Lead meetings with Regulatory Authorities.Oversee regulatory aspects of internationalising products and applying for reclassification of products.Monitor and interpret regulatory trends and changes relevant to the industry, and proactively keep the company informed.Collaborate cross-functionally with Quality and Commercial/Marketing teams to achieve company objectives.Knowledge & ExperienceHighly resilient and adaptable, able to work under pressure and within time constraints.Willing to roll up sleeves to complete tasks.Results-driven and persistent in seeing tasks through to completion.Strong knowledge of global regulatory frameworks.Knowledge of MRP, DCP, CP.Knowledge of medical devices is highly desirable.Excellent attention to detail and organizational skills.Capable of working independently and taking responsibility for actions.8-10 years of previous experience is essential.Attractive benefits package. Salary is negotiable.
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