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Regulatory affairs manager

Dublin
Besins Healthcare
Regulatory affairs manager
Posted: 20h ago
Offer description

2 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Besins HealthcareRecruitment Officer at Besins HealthcareAbout UsWe are a pioneering, family-owned pharmaceutical company dedicated to advancing the development and global commercialization of reproductive hormone therapies that support the lifelong health and well-being of both men and women. To complement our core offerings, we also provide high-quality food supplements and medical devices.Our products are widely used in gynaecology, fertility, obstetrics, and endocrinology. With a presence in over 90 countries through a strong network of subsidiaries and distributors, we continue to grow sustainably. Today, we operate with approximately 1,500 employees, 22 subsidiaries, and 5 manufacturing sites. Our continued success is built on attracting exceptional talent and fostering a collaborative, growth-focused environment.Position:We are seeking an experienced Regulatory Affairs Manager to lead EU regulatory operations and manage global marketing authorisation applications (MAAs), new product development, and lifecycle management activities across the Besins Healthcare portfolio. This role includes direct line management responsibilities.Key Responsabilities :Evaluate and propose the most appropriate regulatory strategy for new product development and life cycle maintenance of Besins Healthcare products for global markets.Provide effective leadership and mentorship to a team of regulatory affairs professionals.Preparation and filing of regulatory submissions for new marketing authorisations and life cycle management, including labelling updates, renewals, MA transfers etc., review of documentation, and publishing as relevantProvide input on impact of new change controls on licences in global markets and facilitate implementation of these as relevantMaintain clear, high-quality communication with internal teams (Quality, Medical, Clinical, Supply Chain, PMO, Pharmacovigilance, Industrial, Legal, and local RA managers) and external stakeholders.Prepare status reports and metrics for assigned projetsPromote best practices in regulatory operations and the use of digital regulatory platforms.Ensure regional regulatory experience and opportunities, obtained through regular regional contacts and collaboration, is fed back into relevant regulatory strategiesJob Requirements:Several years of regulatory affairs and direct management experienceScientific degree at Master of Science levelStrong leadership and team management skills.Excellent organizational skills with the ability to manage multiple priorities.Ability to communicate efficiently with internal and external stakeholders globallyInterested? Please apply!Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionManufacturingIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Besins Healthcare by 2xGet notified about new Regulatory Affairs Manager jobs in Dublin, County Dublin, Ireland.Dublin, County Dublin, Ireland 2 weeks agoGlobal Regulatory Affairs Manager (Global Program Regulatory Manager)Dublin, County Dublin, Ireland 2 days agoDublin, County Dublin, Ireland 5 days agoDublin, County Dublin, Ireland 2 months agoDublin 1, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 1 week agoGlobal Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager)Dublin, County Dublin, Ireland 2 days agoJob Posting Title Global Regulatory Affairs Manager (Global Program Regulatory Manager)Dublin, County Dublin, Ireland 2 days agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 6 days agoDublin, County Dublin, Ireland €50,000.00-€55,000.00 3 weeks agoDublin, County Dublin, Ireland 6 days agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 1 week agoProduct Owner Global Regulatory Affairs (m/f/d)Dublin, County Dublin, Ireland 2 months agoFS Business Consulting - Finance & Risk Regulatory Reporting - Manager - DublinDublin 2, County Dublin, Ireland 1 week agoFS Business Consulting - Finance Regulatory Reporting and Transformation - Manager - DublinDublin 2, County Dublin, Ireland 1 week agoComplaints Program Manager, Regulatory OperationsDublin, County Dublin, Ireland 6 days agoDublin, County Dublin, Ireland 5 days agoManager - Regulatory Advisory for Banking & Capital MarketsDublin, County Dublin, Ireland 1 week agoProgram Manager, Regulatory Information ResponseDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 3 weeks agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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