Regulatory Affairs Manager
7 giorni fa
Managing Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title: European Regulatory Affairs ManagerLocation: Milan, Italy - HybridRemuneration: Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the small team and lead several Regulatory Affairs activities for an established generics portfolio.This role will have a main focus on European submissions through MRP, DCP, and National procedures and also support UK and IRE submissions.The position will be responsible for managing regulatory submissions, new registrations, and variations applications for a range of different generic products marketed in the UK, IRE, and Europe.ResponsibilitiesManage required regulatory processes for UK and European products including submitting submissions through National MRP and DCP.Drive all pre-submission meetings including inputting into scientific advice meetings.Be responsible for all initial/new MAA applications into main EU countries.Following MA approvals ensure product maintenance including submission of national variations or notifications.Ensure EU and UK product labelling approval and compliance with the MA approval activities.Successfully interact with the MHRA and any EU UK Regulatory Authority. Ensuring that regulatory processes are completed, and products are launched in line with regulatory requirements.Generate and implement local procedures and processes to ensure regulatory compliance is met for EU and UK portfolios.RequirementsBachelor’s degree or higher in Life Sciences or technical field.7 to 10 years of relevant regulatory experience especially within the UK and European markets. Submitting through MRP, DCP and national procedures.A strong communicator who is able to navigate through difficult conversations with senior stakeholders.Good team working skills, able to influence to achieve objectives.This position allows for the right candidate to work for a leading generics manufacturer and take charge of UK and European submissions. The role will play a pivotal part in the Regulatory Affairs team and ensure all compliance. The role includes some excellent benefits including a generous bonus scheme.To apply for this role, you must have the full right to work in Europe as this employer does not provide sponsorship. For more information, please contact #J-18808-Ljbffr
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Regulatory Affairs Manager
1 settimana fa
Milan, Italia Altro A tempo pienoMissionDevelop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards. Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.Regulatory affairs Manager is responsible for ensuring that every product their company sells meets relevant...
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Regulatory Affairs Manager
1 settimana fa
Milan, Italia Altro A tempo pienoMission Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards. Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.Regulatory affairs Manager is responsible for ensuring that every product their company sells meets relevant...
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European Regulatory Affairs Manager
7 giorni fa
Milan, Italia Altro A tempo pienoA leading pharmaceutical company in Milan is seeking an experienced European Regulatory Affairs Manager to manage regulatory submissions for generic products in the UK and Europe. You will ensure compliance with regulatory requirements, drive pre-submission processes, and maintain product approvals. The ideal candidate has a strong background in regulatory...
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Regulatory Affairs Manager
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Milan, Italia Altro A tempo pienoAt Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where "Health for all, Hunger for none" is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
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Regulatory Affairs Manager
3 giorni fa
Milan, Italia Altro A tempo pienoAt Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where "Health for all, Hunger for none" is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
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Regulatory Affairs Manager
23 ore fa
Milan, Italia Altro A tempo pienoJoin to apply for the Regulatory Affairs Manager (m/f/d) role at BayerAt Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where “Health for all, Hunger for none” is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique...
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Regulatory Affairs Specialist
7 giorni fa
Milan, Italia Altro A tempo pienoOverview Join to apply for theRegulatory Affairs Specialist (L.68/99)role atAstraZenecaAre you ready to make a difference in the world of healthcare? As a Regulatory Affairs Specialist within the Italian Marketing Company, you will play a crucial role in achieving and maintaining regulatory authorizations for new and existing products. You will support the...
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REGULATORY AFFAIRS MANAGER
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Regulatory Affairs Specialist
1 settimana fa
Milan, Italia Altro A tempo pienoAre you ready to make a difference in the world of healthcare? As a Regulatory Affairs Specialist within the Italian Marketing Company, you'll play a crucial role in achieving and maintaining regulatory authorizations for new and existing products. You'll support the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead, ensuring...
