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Global Regulatory Affairs Specialist, Udine
Client:
Location:
Job Category:
Other
-
EU work permit required:
Yes
Job Reference:
8160257735766573056337118
Job Views:
1
Posted:
08.05.2025
Expiry Date:
22.06.2025
Job Description:
Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies in the world, with over 80 years of experience in the pharmaceutical and biotechnology industry – is expanding its team. IQVIA is recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international work environment.
Purpose:
As a core member of the GRT and strategic partner of the GRL, leverage regulatory expertise to define and execute aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives.
Support development and execution of Global Regulatory Strategy for the TPP.
Ensure alignment of TPP with core product labelling for development and lifecycle management in assigned regions.
Main Responsibilities:
* Serve as a regional/local regulatory lead and point of contact internally and with Health Authorities.
* Contribute to global HA interaction strategies in collaboration with GRT.
* Develop and lead Health Authority engagement and interaction plans, including authoring and moderating meetings.
* Maintain accurate communication and tracking with relevant HAs for assigned projects/products.
* Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core global dossiers, and collaborate with GRT members as needed.
* Align regulatory submission timelines with program and company objectives.
* Contribute to content and review of regulated documents.
* Support operational and compliance activities, including HA contact reports (EU & extra-EU).
* Assist with GMP, GCP, and GPV inspections from health authorities.
* Provide project and submission status updates at GRT meetings.
* Support GRL with updates to affiliates and interactions with IMDD and partners.
Experience Required:
Approximately 3 years' experience in Regulatory Affairs.
Education:
Details not specified.
Languages:
Details not specified.
Technical Skills:
* Understanding of clinical development of drugs and biologics.
* Knowledge of lifecycle management activities (EU and major extra-EU countries).
* Ability to work with electronic document management systems like Veeva Vault.
* Ability to handle multiple projects simultaneously.
* Sensitivity to multicultural/multinational environments.
Soft Skills:
* Stress management
* Time management
* Planning and organizational skills
* Strategic thinking
We offer:
* Competitive salary package
* Permanent contract
* Chemical contract
IQVIA reserves the right to evaluate candidates with relevant domicile/residence and work/study experience. Applications lacking required qualifications will not be fully considered. Please authorize the processing of personal data per GDPR regulations. This research is urgent and open to candidates of all genders (L.903/77).
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