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Pharma Affairs Associate Director
1 settimana fa
La divisione Life Science di Randstad Professionals, specializzata nella ricerca e selezione di profili di Middle & Senior Management, ricerca per importante multinazionale farmaceutica che opera in ambito specialistico un/una:
Regulatory Affairs Associate Director
La risorsa, riportando al General Manager, dovrà gestire in toto la Direzione Affari Regolatori, il Market Access e in dotted line l'Assicurazione Qualità per un totale di 4 persone.
Inoltre, in qualità di responsabile del servizio scientifico, in base alla normativa locale, dovrà garantire che i materiali e le attività locali (promozionali e non) siano conformi alla legislazione, oltre che agli standard aziendali, alle SOP e alla normativa.
Nel dettaglio:
- Garantire l'implementazione del Sistema di Qualità Aziendale nella filiale locale ed essere il punto di contatto con il dipartimento Qualità EMEA.
Supportare l'EU-QPPV come persona di contatto locale per la farmacovigilanza. - Gestire le attività regolatorie locali ed essere il punto di contatto con il dipartimento Regulatory dell'EMEA.
- Essere il contatto principale tra le autorità sanitarie (AIFA e Ministero della Salute) e la filiale locale
- Garantire tutte le azioni di Qualità/Regolamentazione necessarie per il lancio di nuovi prodotti.
- Gestire tutte le questioni e le esigenze relative alla Qualità in linea con il Dipartimento Qualità EMEA, coordinando 1 risorsa locale. Punto di contatto di riferimento dell'Autorità nazionale per le questioni relative alla Qualità (reclami, richiami, carenze).
- Comunicare i reclami dei prodotti all'Autorità Competente e gestire le richieste dell'Ufficio Qualità AIFA.
- Monitorare gli eventi avversi riportati sul sito web dell'AIFA relativi ai prodotti e riferire al reparto FarmacoVigilanza dell'UE per qualsiasi necessità.
- Raccogliere informazioni/insight in merito alle Regolamentazioni (incluso Pharmacovigilance) sui requisiti locali (sia esistenti che nuovi) e condividerle continuamente con i colleghi RA e PV della regione EMEA.
- Responsabilità per i percorsi di rimborso, coinvolgendo le principali parti interessate del settore sanitario. (Pricing & Reimbursement)
- Sviluppare piani di accesso al mercato completi, delineando le strategie per il lancio di prodotti di successo e la presenza costante sul mercato.
- Implementare le strategie di accesso, assicurando l'inclusione dei prodotti nei prontuari, ottenendo rimborsi favorevoli e superando le barriere di accesso.
- Monitorare e gestire le attività di Front End dell'AIFA, come budget, payback, negoziazione e informazioni scientifiche.
- Assistere i responsabili ITR locali/funzionali nella divulgazione della trasparenza;
- Fornire consulenza ai responsabili aziendali/funzionali locali sui codici industriali/regole locali che regolano le interazioni con gli HCP e gli HCO;
- Responsabile di tutti i processi per la certificazione Farmindustria
Requisiti:
- Regolamentazione GCP e Studi Clinici (must)
- Procedure e linee guida EU e National (must)
- Normative GMP/GDP (must)
- Inglese avanzato (must)
- Esperienza pregressa negli aspetti chiave del Processo Regolatorio (must)
Ai sensi della normativa vigente l'offerta di lavoro si intende rivolta a entrambi i sessi (L. 903/77). I dati saranno trattati e conservati esclusivamente per finalità di selezione presenti e future, garantendo i diritti di cui agli artt. 7 e 13 del D. Lgs 196/2003 sulla tutela della privacy.
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