Regulatory Affairs Manager
1 giorno 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-18808-Ljbffr
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Regulatory Affairs Manager
1 giorno fa
Monza, Italia Scienta A tempo pienoDirect message the job poster from Scienta 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...
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Regulatory Affairs Manager
15 ore fa
Monza, Italia Altro A tempo pienoDirect message the job poster from Scienta Partnering with CDMOs to strengthen their Commercial TeamsWe'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...
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Regulatory Affairs Manager
16 ore fa
Monza, Italia Scienta A tempo pienoDirect message the job poster from ScientaPartnering with CDMOs to strengthen their Commercial TeamsWe'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...
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Regulatory Affairs Manager
4 settimane fa
Monza, 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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Regulatory affairs manager
4 settimane fa
Monza, 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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Regulatory Affairs Manager
7 giorni fa
Monza, 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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Regulatory Affairs Manager
6 giorni fa
Monza, 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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Regulatory Affairs Manager
6 giorni fa
Monza, 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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Regulatory Affairs Manager
6 giorni fa
Monza, 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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Regulatory Affairs Manager
5 giorni fa
Monza, 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...
