Regulatory Affairs Manager
7 giorni fa
Partnering with CDMOs to strengthen their Commercial Teams We're currently partnering with a leading global consumer health business to find an experienced Global Regulatory Operations Medicine Manager to join their dynamic Regulatory Affairs team.This is an exciting opportunity to lead end-to-end regulatory operations across a diverse portfolio of over-the-counter (OTC) and consumer health products.You'll be working at the heart of a fast-paced, innovation-driven environment, driving dossier strategy, managing global submissions, and collaborating closely with cross-functional teams across markets.ResponsibilitiesLead Regulatory Submissions: Oversee the planning, preparation, and timely submission of regulatory documentation (e.g., eCTD Modules 1–5) for product registrations, variations, renewals, and withdrawals, ensuring accuracy and compliance.Coordinate Stakeholder Engagement: Serve as the primary regulatory contact for designated product categories (e.g., analgesics), fostering effective communication with internal teams and external partners.Maintain Dossier Integrity: Manage the creation and upkeep of core product dossiers, ensuring alignment with current regulatory requirements and submission timelines.Ensure Documentation Readiness: Supervise the organisation and electronic archiving of regulatory records to support accessibility and inspection readiness.Collaborate Across Functions: Work cross-functionally with Regulatory Strategy, R&D, Pharmacovigilance, Quality, and Marketing to ensure regulatory alignment throughout the product lifecycle.RequirementsDegree in Pharmacy, Life Sciences, or a closely related field (Bachelor's or Master's level).At least 5 years of hands-on experience in regulatory affairs within the pharmaceutical or healthcare sector.Strong command of international regulatory guidelines (e.g., EMA, ICH, and national health authorities).Solid track record in preparing and submitting eCTD dossiers, including CMC M3 content development.Highly organised with excellent attention to detail and ability to manage multiple regulatory projects simultaneously.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionStrategy/Planning and Writing/EditingPharmaceutical Manufacturing, Consumer Services, and Biotechnology Research#J-*****-Ljbffr
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Agronomist / Regulatory Affairs Manager (M/F/D)
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Lazio, Italia Altro A tempo pienoA global healthcare company is seeking a Non-Pharma Global Regulatory Affairs Manager based in Milan.The role involves managing regulatory documentation, executing global regulatory strategies, and ensuring compliance for non-pharma products.Candidates should have proven experience in Regulatory Affairs, a background in life sciences, and strong...
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Italy Regulatory Affairs Manager
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Lazio, Italia Resourcing Life Science A tempo pienoA leading life sciences company in Italy is seeking a Regulatory Affairs Manager to oversee regulatory submissions and engage with authorities to support product registrations.The ideal candidate must possess at least 8 years of regulatory affairs experience, including 4 years in a managerial role.Strong knowledge of EMEA and FDA requirements is...
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Regulatory Affairs Specialist
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Lazio, Italia Altro A tempo pienoRegulatory Affairs Specialist -Medical DevicesJoin to apply for theRegulatory Affairs Specialist -Medical Devicesrole atNordberg MedicalRegulatory Affairs Specialist -Medical DevicesJoin to apply for theRegulatory Affairs Specialist -Medical Devicesrole atNordberg MedicalGet AI-powered advice on this job and more exclusive features.TheRegulatory Affairs...
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Category Regulatory Affairs Manager
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Lazio, Italia Altro A tempo pienoDescription Overview Perrigo is seeking a dynamic and experienced Regulatory Affairs Manager to lead regulatory strategy and execution for our biocidal product portfolio across multiple territories.This role offers a unique opportunity to shape regulatory pathways, drive compliance excellence, and lead a high-performing team within a fast-paced,...
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Lazio, Italia Resourcing Life Science A tempo pienoWhat to ExpectConduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements.Manage annual registrations, license renewals, and ongoing regulatory notifications.Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation.Coordinate the...
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Lazio, Italia Altro A tempo pienoA leading pharmaceutical company seeks a Senior Regulatory Affairs Consultant in Italy.This role involves developing international regulatory strategies, managing submissions, and leading regulatory teams.Candidates should have over 10 years of experience in the pharmaceutical industry, a relevant scientific degree, and strong knowledge of regulatory...
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Line Manager
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Lazio, Italia Resourcing Life Science A tempo pienoWhat to ExpectLine management, training of Regulatory SpecialistTraining of the direct reports in EMEA / FDA requirementsEstablish and manage regulatory submission timelines for both new and existing products across key global marketsEngage with regulatory authorities and distribution partners to support product registrationsConduct global regulatory impact...
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Senior Regulatory Affairs Specialist
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Lazio, Italia Acarpia Farmaceutici S.R.L. A tempo pienoRegulatory Affairs Senior Specialist – ACARPIA Farmaceutici ACARPIA Farmaceutici è alla ricerca di una figura da inserire nel proprio team come Regulatory Affairs Senior Specialist.Il candidato sarà coinvolto in tutti gli aspetti del processo di registrazione e mantenimento dell'autorizzazione all'immissione in commercio (AIC) tramite rinnovi, variazioni...
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Regulatory Affairs
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Lazio, Italia Claire Joster | People First A tempo pienoUn'agenzia di selezione di personale sta cercando un Certifications and Regulatory Affairs Specialist per garantire la conformità regolamentare dei prodotti in plastica e packaging cosmetico.La figura si occuperà di collaborare con i vari reparti aziendali e supportare lo sviluppo di nuovi prodotti, assicurando il rispetto delle normative UE e...
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Lazio, Italia During S.P.A. Filiale Di Crema A tempo pienoRandstad Talent Selection, divisione di Randstad Italia specializzata nella Ricerca & Selezione di candidati qualificati, ricerca per azienda chimico farmaceutica unREGULATORY AFFAIRS SENIOR OFFICERSi offre : inserimento a scopo assunzione a tempo indeterminatoLuogo di lavoro : Aprilia (LT)Retribuzione annua : *****€ - *****€esperienza2 anniSi richiede...
