Global Regulatory Affairs Specialist

Social network you want to login/join with:
Global Regulatory Affairs Specialist, NovaraClient: Location: Job Category: Other
-
EU work permit required: Yes
Job Reference: 8160257735766573056337127
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 worldwide, with over 80 years of experience in the pharmaceutical and biotechnology industry – is expanding their team.
IQVIA is recruiting a Global Regulatory Affairs Specialist to join a dynamic, international 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 strategies for the TPP, ensuring alignment of TPP with core product labeling for development and lifecycle management.
Main Responsibilities:Serve as a regional/local regulatory lead and point of contact internally and with health authorities.Contribute to developing global HA interaction strategies with GRT guidance.Develop and manage HA engagement and interaction plans for assigned products, including authoring and leading meetings.Communicate and track interactions with relevant HAs for projects/products.Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core dossiers, and collaborate with GRT members.Align regulatory submission timelines with program and company objectives.Contribute to and review regulated documents.Support operational and compliance activities, including HA contact reports (EU & extra-EU).Support GMP, GCP, and GPV inspections.Provide updates on project and submission status at GRT meetings.Support GRL updates and interactions with affiliates, IMDD, and partners.Experience Required:Approximately 3 years of experience in Regulatory Affairs.
Education:Not specified.
Languages:Not specified.
Technical Skills:Understanding of clinical development of drugs and biologics.Knowledge of lifecycle management activities in EU and major extra-EU countries.Proficiency with electronic document management systems like Veeva Vault.Ability to handle multiple projects simultaneously.Sensitivity to multicultural/multinational environments.Soft Skills:Stress managementTime managementPlanning and organizational skillsStrategic thinkingWe Offer:Competitive salary packagePermanent contractChemical contractIQVIA reserves the right to evaluate candidates based on domicile/residence, work experience, and studies aligning with the requirements.
Applications lacking these requirements will not be fully considered.
Please provide authorization for personal data processing under GDPR (DL196/2003, GDPR 679/16).
The research is urgent and open to candidates of all genders (L.903/77).

#J-18808-Ljbffr