RA MSR/Renewal/Tender Coordinator

Descrizione dell'offerta

  Categoria professionale
Scientifico / Farmaceutico - Regulatory affairs specialist
·  Settore
INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
·  Località
Siena, Siena
·  Data inizio
01/09/2018

The MSR/Renewal/Tender Coordinator ensures timely regulatory submission and approval of new files, variations, renewal files and/or tenders for the Company in EU and/or international countries by efficiently coordinating the preparation, compilation and/or management of official documents and other market specific requirements required by the local (regulatory) Authorities. He/She must to provide documents and international renewals in compliance with the quality standards of worldwide Regulatory Authorities and Company internal standards.

He/She can also provide technical/coordination support and coaching/expertise, in particular for the R&D, the QA Department, the legal Department to ensure the appropriate project management related to MSR/Renewal/tender process/projects with the different stakeholders by issuing the master planning/strategy to ensure timely and smoother implementation within Company organization.
The MSR/Renewal/Tender Coordinator is recognized as MSR/Renewal/tender expert within and outside the team. He/she is responsible to identify, develop and implement the adequate strategies to meet business requirements. He/She looks for continuous process improvement and is pro-active in identifying and implementing the needed business requirements to ensure business continuity and contributes to GRA alignment for MSR/Renewal/tender business.
As a MSR/Renewal/Tender expert, he/she ensures the maintenance of high level business knowledge and regulatory evolutions trends in his/her field activity.

Key Responsibilities:
The MSR/Renewal/Tender Coordinator ensures the following project management for MSR/Renewal/Tender by:
1.planning, coordinating and/or preparing and delivering the renewal files registered via the national route in the countries assigned and the requests by LOC for market specific documents to ensure a timely submission by the different Authorities.
2.liaising with LOCs and other stakeholders for efficient coordination of the needed support and timely dispatch of the dossiers and business objectives.
3.supporting the LOCs for their submission to their authority by providing help and guideline on procedural and administrative matters.
Required skills:
• Fluency in spoken & written English
• Confirmed RA knowledge, skills in information, document and database management
• Stress-resistant
• Flexibility

Temporary until the end of December 2018.

Titolo di studio:
Laurea Magistrale - Chimico / Biologico / Ambientale

Lingue conosciute:
Inglese: Parlato Ottimo - Scritto Ottimo - Comprensione Ottimo

Disponibilità oraria: Full Time

CCNL: Chimico Farmaceutico-Industria