Regulatory Intelligence Specialist

1 mese fa

Milan, Italia Parexel A tempo pieno

When our values align, there's no limit to what we can achieve.
 

We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to join our team. As a Regulatory Intelligence Specialist , you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and implements relevant requirements. You will collaborate closely with stakeholders, contribute to continuous improvement of our Quality Management System (QMS), and play a crucial role in maintaining our compliance standards.

Key Responsibilities:

Lead and coordinate all Regulatory Intelligence activities, including research on regulatory updates, communication to stakeholders, and tracking the impact and implementation actions.

Act as the point person for regulatory intelligence related consultancy.

Assist the Parexel Quality group in the preparation for and follow-up of internal/external audits and inspections, as needed and relevant to Regulatory Intelligence Activities.

Maintain the Regulatory Intelligence SharePoint and filing areas.

Provide technical knowledge where appropriate.

Collaborate with Parexel Quality to develop and update quality/process documents, tools, and templates in line with regulatory intelligence activities.

Generate metrics on Regulatory Intelligence Activities.

Contribute to the metrics provided to Senior Management.

Complete assigned goals for key QMS elements, with a special focus on Knowledge Management/Regulatory intelligence activities and oversight.

Undertake other duties as assigned.

Skills and Experience required for the role:

Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience.

Experience in Quality Assurance, Quality Management, Regulatory Affairs, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant areas.

Good understanding of regulatory affairs landscape

Experience working with clinical trials

Project management capabilities applicable to Regulatory Intelligence activities and oversight.

Excellent interpersonal, verbal, and written communication skills, including the ability to present at meetings and training sessions.

Ability to rapidly learn, understand, and apply applicable corporate procedures.

Excellent time management skills, with the ability to prioritize workload and manage multiple tasks/projects with enthusiasm.

Ability to lead projects and teams.

Strong ability to analyze and interpret data.

Attention to detail and advanced organizational skills.

IT literate, with a strong ability to work with Microsoft-based applications and relevant Regulatory Intelligence applications such as Cortellis or Tarius

Proficiency in written and oral English.

  • Artificial Intelligence Technical Specialist

    4 mesi fa

    Milan, Italia Vodafone A tempo pieno

    Role Purpose Artificial intelligence evolution for the fixed network solutions fulfilment for PA customers Key accountabilities and decision ownership • Autonomy: Ability to work independently and make informed decisions. • Problem Solving: Skill in effectively solving complex problems. • Time Management: Excellent time management...

  • Regulatory CMC Specialist

    1 settimana fa

    Milan, Italia Eurofins Italy BioPharma Product Testing A tempo pieno

    Descrizione del lavoroEurofins Regulatory and Consultancy Services Italy è alla ricerca di un Regulatory CMC Specialist con esperienza, autonomo e con una solida conoscenza del settore.La risorsa sarà responsabile di supportare e guidare i clienti nella gestione dei requisiti di Chemistry, Manufacturing and Controls (CMC) per lo sviluppo e la registrazione...

  • Business Intelligence Specialist

    6 mesi fa

    Milan, Italia Gruppo MutuiOnline S.p.A. A tempo pieno

    Descrizione azienda Mavriq, divisione B2C di Moltiply Group, è la tech company a cui appartengono alcuni tra i più importanti brand di comparazione ed intermediazione online in Italia (MutuiOnline.it, Segugio.it, SOStariffe.it, Trovaprezzi.it e molti altri) e all’estero (LeLynx.fr, Rastreator.com e Rastreator.mx). I servizi offerti dai brand di...

  • Network, Regulatory

    2 mesi fa

    Milan, Italia Groupe iliad A tempo pieno

    Il Network, Regulatory & Wholesale Affairs Specialist – Legal Counsel per il Gruppo Iliad Italia (Iliad) è un componente attivo del Legal Team di Iliad. In tale qualità, il Network, Regulatory & Wholesale Affairs Specialist , riportando al Lead di riferimento e in coordinamento con quest’ultimo, anche seguendo le indicazioni del General Counsel e...

  • Regulatory Affairs Specialist

    6 mesi fa

    Milan, Italia Italgas A tempo pieno

    Gruppo Italgas Siamo il primo operatore in Italia nella distribuzione del gas e il terzo in Europa. Siamo presenti anche in Grecia attraverso Depa Infrastructure, principale leader ellenico del settore. Oltre al gas, ci occupiamo anche di acqua in Campania e, grazie a Geoside, operiamo nel mercato dell’efficienza energetica, con un’offerta...

  • Associate Director, Regulatory Affairs

    1 mese fa

    Milan, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs - Medical Device/ Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due...

  • Associate Director, Regulatory Affairs

    4 settimane fa

    Milan, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs - Medical Device/ Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due...

  • Associate Director, Regulatory Affairs

    3 settimane fa

    Milan, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...

  • Associate Director, Regulatory Affairs

    3 settimane fa

    Milan, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...

  • Regulatory Affairs Specialist

    4 settimane fa

    Milan, Italia HUNTERS GROUP A tempo pieno

    Per azienda cliente, realtà leader nel settore farmaceutico e cosmetico in Italia, siamo alla ricerca di una figura di Regulatory Affairs Specialist - Medical Devices.Redigere e aggiornare la documentazione relativa alla legislazione e alle linee guida degli enti regolatori nazionali ed internazionali con cui ci si interfaccia;Assicurare la conformità del...

  • Business Intelligence Specialist

    4 settimane fa

    Milan, Italia Mavriq A tempo pieno

    Mavriq, divisione B2C di Moltiply Group, è la tech company a cui appartengono alcuni tra i più importanti brand di comparazione ed intermediazione online in Italia (MutuiOnline.it, Segugio.it, SOStariffe.it, Trovaprezzi.it e molti altri) e all’estero (LeLynx.fr, Rastreator.com e Rastreator.mx). I servizi offerti dai brand di Mavriq aiutano con...

  • Junior Regulatory Reporting Specialist

    2 settimane fa

    Milan, Italia Banca Ifis S.p.A. A tempo pieno

    Banca Ifis SpA non è una banca tradizionale, è la banca che ispira chi ha voglia di creare, competere, crescere e che occupa una posizione unica nel panorama bancario italiano. Siamo smart, flessibili ed efficaci e crediamo nella continua innovazione. La nostra strategia di crescita è basata su competenze di alto livello ed elevate capacità di visione....

  • RA Specialist Medical Devices

    3 mesi fa

    Milan, Italia Page Personnel A tempo pieno

    We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will play a key role in ensuring compliance with regulatory requirements for our medical devices. This individual will collaborate cross-functionally with internal teams to support product development, registration, and...

  • Medical Devices Regulatory Affairs Specialist

    7 giorni fa

    Milan, Italia Aeffe S.r.l. A tempo pieno

    Per un’importante e riconosciuta Realtà Internazionale che opera nel campo Dermocosmesi, Dispositivi Medici ed Integratori e che fonda l’eccellenza dei suoi prodotti su ricerca, tecnologia e qualità, siamo alla ricerca di un/una Medical Device RA SpecialistPosizione: La persona si occuperà di supportare il Regulatory Affairs Manager e la Direzione...

  • AI Innovation Specialist

    1 mese fa

    Milan, Italia Page Personnel A tempo pieno

    Evaluate and select AI services suitable for business needsImplement AI solutions to optimize business processesCollaborate with product and development teams to integrate AI technologiesMonitor and analyze the performance of implemented AI solutionsInteresting for emerging AI technologiesPython or other similar languagesWe are looking for an AI Specialist...

  • Principal Regulatory Affairs Consultant

    2 mesi fa

    Milan, Italia Parexel A tempo pieno

    When our values align, there's no limit to what we can achieve.   Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong...

  • Regulatory and Start Up Specialist 2

    5 mesi fa

    Milan, Italia IQVIA A tempo pieno

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Specialized in ICF. Essential Functions Under...

  • Regulatory Affairs Specialist

    2 settimane fa

    Milan, Italia Antal International Network A tempo pieno

    Il/la candidato/a farà parte della divisione Regulatory Affairs di una nota realtà chimico-farmaceutica nostra cliente. Responsabilità: Gestione dei processi regolatori per la registrazione di Dispositivi Medici (MDR-Regolamento EU 2017/745 e linee guida MDCG correlate; ISO 13485; ISO 14971; ISO 14155; ISO 10993) nel rispetto dei requisiti previsti dalla...

  • Central Compliance and Regulatory Management Specialist

    6 mesi fa

    Milan, Italia 0896 Deutsche Bank Società per Azioni A tempo pieno

    Description : The Compliance Italy team is looking for a Central Compliance and Regulatory Management specialist to be included in the team. She/he will support the team in the management of the interactions with local and global Regulators and will report to the Head of Central Compliance Italy. Main responsibilities The Central Compliance Officer...

  • Senior RA Specialist

    4 mesi fa

    Milan, Italia CooperCompanies A tempo pieno

    Job title: Senior RA Specialist (SEC) Department: Regulatory Affairs Location: Delta Park, Fareham/Hybrid GLS: P3 Working hours: 37.5 Weekly A brighter future awaits you CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way...