8616 - Regulatory Affairs Associate III

Lombardia -> Milano -> Rho

RESPONSIBILITIES: 1. Manages the regulatory aspects and related tasks of the assigned commercial APIs 2. Performs activities, while keeping the knowledge up to date, based on Teva policy and guidelines of the international Regulatory Authorities. 3. Proactively collaborates with the Regulatory Administrative team members, which release and submit the finalized API’s dossier or documentation. MAIN ACTIVITIES: 1. Maintain up to date the various dossiers filed to the relevant regulatory Authorities, by submission of DMF amendments or total updates in a suitable format, while managing the upgrade of the technical content of the file, according to the available information. 2. In order to improve the business in the new markets, develop a dossier in line with Teva policy and in compliance with the local Authority requirements. 3. Reply to additional information requests from Health Authorities (clarification or lack of information on the technical content of the file), while proactively interfacing with the relevant departments, in order to collect and elaborate appropriate answers to the questions raised. 4. Support customers as a RA assignee of Service Requests, giving relevant information with professional answers. 5. Participate, if needed, to internal meetings (with production, QA, QC and R&D) or conferences with customers or marketing staff, in order to help solving technical or commercial issues. Qualifications: Education: Minimum: University Scientific Degree Preferred: Specialty in Chemistry, Industrial Chemistry or Chemistry and Pharmaceutical Technologies Experience: Minimum: 5 years work experience in R&D or Regulatory in a fine chemical industry. E indispensabile per l'esecuzione della posizione l'esperienza Senior in API-Regulatory Affairs Skills: English Language: good professional level, both in writing and speaking

Numero di posizioni ricercate
1
Titoli di studio preferenziali
Master
Necessità di iscrizione all'albo
NO
Competenze linguistiche
Inglese Ottimo
Livello minimo di esperienza richiesta
7-10
Tipo di contratto
Tempo indeterminato
Disponibilità oraria
Full time
Offerta pubblicata il
11.01.2019
L'offerta è da intendersi come rivolta a candidati ambosessi (D.lgs 151/2001, D.lgs 198/2006) e valida per tutte le nazionalità ed età, fermi restando i limiti di età fissati dalla normativa vigente per specifiche tipologie contrattuali

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Inserzionista

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Azienda
Produzione API

Via Terrazzano, n. 77
Rho - Milano

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