Regulatory Affairs Manager
8 ore fa
Direct message the job poster from ScientaPartnering with CDMOs to strengthen their Commercial TeamsWe'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 organization 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/EditingIndustriesPharmaceutical Manufacturing, Consumer Services, and Biotechnology ResearchReferrals increase your chances of interviewing at Scienta by 2xGet notified about new Regulatory Affairs Manager jobs in Monza, Lombardy, Italy.#J-*****-Ljbffr
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Regulatory Affairs Manager
1 giorno fa
Lazio, Italia Scienta A tempo pienoWe'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...
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European Regulatory Affairs Manager
1 giorno fa
Lazio, 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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Medical Device
1 settimana fa
Lazio, Italia Altro A tempo pienoMedical Device – Regulatory Affairs Director ResponsibilitiesLine management of 10 Regulatory Line ManagersEstablish and implement regulatory strategies ensuring new and existing products comply with the latest global requirementsTrain the team on EMEA / FDA requirementsQualificationsMinimum 8 years in regulatory affairs in the medical device...
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Category Regulatory Affairs Manager
4 settimane fa
Lazio, Italia Perrigo Company plc A tempo pienoCategory Regulatory Affairs Manager – Perrigo Company plc Join to apply for the Category Regulatory Affairs Manager role at Perrigo Company plc. At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All . We are proud to be a Top 10 player in the European Consumer Self‑Care market and...
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Category Regulatory Affairs Manager
7 giorni fa
Lazio, Italia Altro A tempo pienoCategory Regulatory Affairs Manager – Perrigo Company plcJoin to apply for the Category Regulatory Affairs Manager role at Perrigo Company plc.At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All .We are proud to be a Top 10 player in the European Consumer Self-Care market and the...
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Category Regulatory Affairs Manager
4 giorni fa
Lazio, Italia Perrigo Company Plc A tempo pienoCategory Regulatory Affairs Manager – Perrigo Company plcJoin to apply for the Category Regulatory Affairs Manager role at Perrigo Company plc.At Perrigo, we are driven by our mission toMakes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All.We are proud to be a Top 10 player in the European Consumer Self-Care market and the...
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Category Regulatory Affairs Manager
2 giorni fa
Lazio, Italia Perrigo Company Plc A tempo pienoCategory Regulatory Affairs Manager – Perrigo Company plcJoin to apply for the Category Regulatory Affairs Manager role at Perrigo Company plc.At Perrigo, we are driven by our mission toMakes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All.We are proud to be a Top 10 player in the European Consumer Self-Care market and the...
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Regulatory Affairs Manager
6 giorni fa
Lazio, Italia Scienta A tempo pienoWe're currently partnering with a leadingglobal consumer health businessto find an experiencedGlobal Regulatory Operations Medicine Managerto 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...
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Lazio, Italia Altro A tempo pienoSenior Manager Regulatory Affairs and PharmacovigilanceJoin to apply for the Senior Manager Regulatory Affairs and Pharmacovigilance role at Novo Nordisk .Do you have a solid experience in regulatory and pharmacovigilance fields?Do you want to take your career path to the next level, in one of the leading companies of the pharma sector?The Italian affiliate...
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Regulatory Affairs Project Manager
3 giorni fa
Lazio, Italia Adama Ltd. A tempo pieno1 day ago Be among the first 25 applicantsJoin ADAMA – A Global Leader in Crop Protection shaping the future of agricultureWith nearly 10,000 employees and $5 billion in annual sales across more than 100 countries, ADAMA is one of the world's top crop protection companies and part of the Syngenta Group.Our mission is to create simplicity in agriculture –...
