Senior Regulatory Affairs Specialist - PharmaSenior Regulatory Affairs Specialist - Pharma1 day ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Amicus Search & RecruitmentSenior Consultant, Sciences & Healthcare Recruitment @AmicusSenior Regulatory Affairs Officer – Pharmaceuticals (Hybrid)Location: Offices based near Clonee, Co. Meath, IrelandOur client, a thriving Irish pharmaceutical group, is experiencing significant growth with market-leading OTC and Prescription medicines across numerous EU countries, Australia, and New Zealand. Due to their continued expansion, they are seeking a highly motivated and experienced Senior Regulatory Affairs Officer to join their growing team. This new position reports into the Regulatory Affairs Manager and offers a fantastic opportunity to make a tangible impact within a dynamic, family-run business that prioritises performance and offers excellent career progression.What You'll Do:As a Senior Regulatory Affairs Officer, you'll play a crucial role in ensuring the company's diverse product portfolio complies with global regulatory frameworks. This is a hands-on role where you'll be expected to get stuck in and drive results. Your key responsibilities will include:Ensuring the company’s products comply with all relevant regulations and standards.Demonstrating knowledge and execution of Type IA, IB, and II Variations.Managing licence transfers in various international territories.Reviewing promotional material for medicinal products.Preparing Module 1 documentation for National Applications.Preparing for and participating in meetings with Regulatory Authorities.Dealing with regulatory aspects of internationalising products and applying for reclassification.Training and mentoring more junior team members on Regulatory processes and compliance requirements.Monitoring and interpreting regulatory trends and changes relevant to the industry, keeping the company appraised of these.What You'll Bring:Our client is looking for a resilient and adaptable individual with a strong sense of ownership and a proven track record in regulatory affairs.Essential Experience & Knowledge:3-4 years of progressive experience in Regulatory Affairs within the pharmaceutical industry (human health).Demonstrable experience with pharmaceutical products, specifically OTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries.Exceptional attention to detail and outstanding organisational skills.Capability to work on your own initiative and take responsibility for your course of action.What’s On Offer:Competitive Salary: A highly competitive salary, negotiable based on your experience.Performance-Based Bonuses: Your hard work and contributions will be recognised and rewarded through performance-based bonuses.Hybrid Working: The company embraces a hybrid working model, requiring you in their offices near Dunboyne, Co. Meath three days a week, with flexibility for remote work 2 days per week. They also offer flexible start and finish times around their contracted 9-5 hours to help avoid peak traffic.Career Progression: With a turnover of €250 million and ambitious growth plans, the opportunities for professional development and career advancement within the company are significant.If you're a seasoned Regulatory Affairs professional looking for a challenging yet rewarding role within a rapidly expanding pharmaceutical group, we encourage you to apply!Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionScience, Quality Assurance, and ResearchIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Amicus Search & Recruitment by 2xSign in to set job alerts for “Regulatory Affairs Specialist” roles.Clonee, County Meath, Ireland 3 weeks agoRegulatory Affairs Specialist - Plant Protection ProductsRegulatory Affairs Manager - PharmaceuticalsDunboyne, County Meath, Ireland 3 weeks agoDunboyne, County Meath, Ireland 2 weeks agoDunboyne, County Meath, Ireland 6 days agoDunboyne, County Meath, Ireland 1 week agoDunboyne, County Meath, Ireland 1 week agoQuality Assurance Specialist 3rd Party ProductsStamullen, County Meath, Ireland 1 month agoQuality Assurance Specialist 3rd Party ProductsWe’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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