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Job Reference:
8160257735766573056337150
Job Views:
1
Posted:
08.05.2025
Expiry Date:
22.06.2025
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Job Description:
Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies worldwide, with over 80 years in the pharmaceutical and biotechnology industry – is expanding its team. IQVIA is recruiting a Global Regulatory Affairs Specialist to join a dynamic and international environment.
Purpose:
The specialist will be a core member of the GRT and a strategic partner to the GRL, leveraging regulatory expertise to define and execute EU, extra-EU, and global regulatory strategies, ensuring alignment across regions to meet business objectives.
Responsibilities include supporting the development and execution of global regulatory strategies, aligning TPP with product labeling, and ensuring compliance with regulatory requirements.
Main Responsibilities:
* Serve as a regional or local regulatory lead and point of contact with health authorities.
* Contribute to global health authority interaction strategies.
* Develop and manage health authority engagement plans, including authoring and leading meetings.
* Maintain accurate communication and tracking with health authorities.
* Lead regulatory sub-teams to ensure timely filings and collaboration on dossiers.
* Ensure regulatory submission timelines align with project and company goals.
* Review and contribute to regulated documents.
* Support operational and compliance activities, including health authority reports.
* Assist with GMP, GCP, and GPV inspections.
* Provide project and submission updates at GRT meetings.
* Support updates to affiliates and interactions with IMDD and partners.
Experience Required:
Approximately 3 years in Regulatory Affairs.
Education:
Details not specified.
Languages:
Details not specified.
Technical Skills:
* Understanding of clinical drug development and biologics.
* Knowledge of lifecycle management activities in EU and major extra-EU countries.
* Experience with electronic document management systems like Veeva Vault.
* Ability to handle multiple projects simultaneously.
* Sensitivity to multicultural/multinational environments.
Soft Skills:
* Stress and time management.
* Planning, organizational, and strategic thinking skills.
We offer:
* Competitive salary.
* Permanent contract.
* Chemical contract.
IQVIA reserves the right to evaluate candidates based on domicile, residence, work experience, and studies. Applications without the required qualifications will not be fully considered. Candidates must consent to personal data processing under GDPR regulations. This research is urgent and open to candidates of all genders (L.903/77).
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