GRA-CMC Specialist

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 2.3.
• 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 define strategy to reach the goal, including identifying the right stakeholders to be involved (CMOs, Manufacturing, R&D) and the right tools to be used (guidance, similar experiences on other products, meetings, e-mails, 1:1 phone calls)
• ability to quickly decide how to move on, and provide references for the decision taken
• 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 high-quality 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 non-EU 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:

Maternity leave

Chemical contract

IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com