Farmaceutica jobs in Italy
Farmacista collaboratore / trice Ostia (RM)
Dr. Max Italia S.R.L.
Impiegato / impiegata back office commerciale customer service con lingua inglese (926423)
Manpower TREZZO SULLADDA S.Marta
Farmacista Collaboratore / Collaboratrice
Farmagorà Holding SpA
Discover more opportunities than anywhere else. Find more jobs nowFARMACISTA - LUINO (VA)
Staff S.p.A. Filiale Permanent
Site Quality Manager - Sostituzione Maternità
365 gradi
Connect with headhunters to apply for similar jobsMS&T Project Manager (fmd)
Temmler Italia
Recruitment Expert - Engineering & Life Science
Antal International
Analista Environmental Monitoring
agap2 Italia
Director Product Quality Management
Johnson & Johnson Innovative Medicine
Process & Computer System Validation Specialist (GCP)
Fintech District
Quality Control Manager
Centro per l'arte contemporanea Luigi Pecci
Sales & Business Development – Medical Device & Pharma Consulting
Fintech District
Medical Scientific Liaison
Daikin Applied Europe
ADDETTI CONFEZIONAMENTO COSMETICO
Jobbit
Informatore scientifico commerciale | Piemonte
PharmaNutra S.p.A.
Operations Maintenance Supervisor
Haleon
Regulatory Affairs Manager
Job summary
A leading global consumer health business in Italy is seeking an experienced Global Regulatory Operations Medicine Manager to join their dynamic team. You will lead regulatory submissions, manage core product dossiers, and collaborate with various functions in a fast-paced environment. The ideal candidate will have a degree in Pharmacy or Life Sciences and at least 5 years of experience in regulatory affairs. Strong organizational skills and attention to detail are essential.
Qualifications
- Bachelor’s or Master’s level degree in Pharmacy, Life Sciences, or related field.
- Minimum 5 years of experience in regulatory affairs in pharmaceuticals or healthcare.
- Familiarity with international regulatory guidelines (EMA, ICH).
- Experience in preparing and submitting eCTD dossiers.
- Ability to manage multiple projects effectively.
Responsibilities
- Oversee the submission of regulatory documentation for product registrations.
- Act as the primary regulatory contact for product categories.
- Manage core product dossiers to ensure compliance.
- Organize and archive regulatory records for inspections.
- Collaborate with various teams for regulatory alignment.
Skills
Education
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.
- Lead Regulatory Submissions : Oversee the planning, preparation, and timely submission of regulatory documentation (e., 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.
- Degree 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.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.