Regulatory Affairs Specialist - MSR / Renewal / Tender

Job description

·  Categoria professionale
Scientifico / Farmaceutico - Regulatory affairs specialist
·  Data fine lavoro
04/04/2021
·  Settore
INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
·  Località
Siena, Siena
·  Data inizio
05/10/2020
·  Riferimento esterno
REGULATORYAFFAIRSSPECIALIST-MSR/RENEWAL/TENDER-0998-543

For a pharmaceutical company, we are looking for a

Regulatory Affairs Specialist - MSR / Renewal / Tender

Job purpose:
The MSR/Renewal/Tender Specialist delivers project management, compliance and regulatory intelligence in the framework of 3 activities:
- Market Specific Requirements (MSR) supporting all worldwide submissions to the impacted authorities
- Renewal of the licences of all registered products (worldwide except for EMA, US and Japan)
- Tender submission file supporting the competitive sales process where the Company responds to an inquiry from a procuring body (National MoH, regional authorities, PAHO, GAVI, Unicef, MSF, etc.), for a contract or bid (worldwide)

The MSR/Renewal/Tender Specialist ensures the following project management for MSR/Renewal/Tender by:
1. Defining the submission strategy of the renewal package with all impacted stakeholders, managing the planning, the coordination and/or preparation, dispatch and follow-up such as Q&A’s, Additional in order to ensure a timely submission to appropriate authorities
2. Supporting the submission strategy for all types of variations regarding the MSR management and coordinating all impacted stakeholders issuing those documents to support the submission
3. Coordinating all impacted GRA stakeholders to support the Tender activities
4. Flagging operational issues and proposing solutions in a timely manner
5. Supporting the LOCs for their submission to their authority by providing help and guideline on procedural and administrative matters
-Ensures the establishment/ maintenance/continuous improvement of SOP’s, working instructions, guidelines related to these 3 processes
-Ensures training of new employees and sharing best practices across GRA business and to external stakeholders.

Minimum requirements:
- Relevant Master of Science Degree and RA Master
- At least 2 years’ experience in activity coordination related to official documents management including the contribution of various stakeholders (e.g. manufacturing, quality, Clinical development)
- Demonstrated capacity to prioritize daily activities/projects. Good organizational, interpersonal and communication skills
- Knowledge of EXPLORE – TDS – DOCUMENTUM – OPAL – BINOCS tools
- Fluent English knowledge

Temporary contract 6 months

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

Competenze:
Browser per Internet - Microsoft Explorer, livello Ottimo

Disponibilità oraria: Totale disponibilità