Gra-cmc Specialist - Milano, Italia - IQVIA
Descrizione
Our client,
Chiesi Farmaceutici - one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of a
GRA-CMC Specialist who can join an exciting working environment in a dynamic and international atmosphere.
JOB PURPOSE:
Management of the CMC regulatory for products under Geographical Expansion and/or Product enhancement (line extensions/renewals/major variations), with the supervision of the manager.
PROFILE:
- Degree in Chemistry, Pharmacy, Chemistry and Pharmaceutical Technologies, Biological Sciences
- Demonstrable and significant experience in a similar position in a pharmaceutical or as a consultant for pharmaceutical companies
- Knowledge and understanding of the CMC regulatory framework for EU, US and RoW areas with regards to Drug Products, Drug Device Combination products and Medical Devices.
- Knowledge of the M3 and 2.3 structure and having a consolidated experience in writing of the M3 and 2.
- Knowledge and understanding of the drug development process.
- Knowledge and understanding of basic computer systems (Word, Excel, Powerpoint)
- Problem solving and decision making:
- ability to quickly identify the core meaning of a request (e.g. to correctly understand a question from the Health Authority, or a request from the development technical team)
- Ability to organise unstructured original information and to generate consistent and accurate final documentation.
- Communication:
- Good quality of written and verbal communication, not only with colleagues but also with Senior Management and Health Authority.
- Delivery of highquality presentations,
- Ability to lead meetings in an organised and controlled way
- Organisation: Time Management, Prioritisation, Decision making
- Resilience to deal with high levels of responsibility, short timescales, ambiguity in roles/responsibilities of the stakeholders and heavy workload.
RESPONSABILITIES:
Regulatory-CMC activities related to EU, US and RoW areas:
- Support the development for line extension/product enhancement (CMC regulatory strategy/IMPD/IND/Briefing Documents )
- Preparation of the Regulatory CMC documents (CTD-Module 3 & 2.3 and relevant Q&A) for line extension products.
- Preparation and alignment of Regulatory CMC documents (CTD-Module 3 & 2.3 plus local requirements and relevant Q&A) for geographical expansion in nonEU areas of products already registered at least in the EU area.
- Preparation of regulatory CMC documents for renewals procedures
- Preparation of variation packages for major variation mainly impacting the development of products having an active Geo Expansion plan.
- Preparation of consolidated dossier of established products for RoW countries that for some major variations require a new submission
TYPE OF CONTRACT:
Permanent contract
Chemical contract
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