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Global regulatory affairs specialist

Milano
Contratto a tempo indeterminato
Iss Iqvia Csms
Pubblicato il 2 agosto
Descrizione

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 through IQVIA. They are recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international working environment.

Purpose:

As a core member of the GRT and a strategic partner of the GRL, leverage your regulatory expertise to contribute to the definition and execution of aligned EU, extra-EU, and/or global regulatory strategies. Work flexibly across regions to ensure the achievement of business objectives.

Support the development and/or execution of the Global Regulatory Strategy to support the TPP, and 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 the development of global HA interaction strategies in collaboration with GRT.
* Develop and execute Health Authority engagement and interaction plans, including authoring and moderating meetings.
* Maintain accurate communication and tracking with relevant HAs for projects/products.
* Lead or support regulatory submissions (NDA, MAA, Variations) ensuring timelines are met, and collaborate with GRT members.
* Ensure submission timelines align with program and company objectives.
* Contribute to and review regulated documents.
* Support operational and compliance activities, including HA contact reports (EU & extra-EU).
* Assist with GMP, GCP, and GPV inspections.
* Provide updates on project and submission statuses at GRT meetings.
* Support updates to affiliates and interactions with IMDD and partners.

Experience Required:

Approximately 3 years of experience in Regulatory Affairs.

Technical Skills:

* Understanding of clinical development of drugs and/or biologics.
* Knowledge of Lifecycle Management activities (EU and major extra-EU countries).
* Experience with electronic document management systems like Veeva Vault.
* Ability to manage 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 based on domicile, residence, work experience, and studies aligning with the role requirements. Applications lacking these requirements will not be fully considered. Candidates must authorize the processing of personal data per GDPR regulations. This research is urgent and open to candidates of all genders (L.903/77).

LICES #LIDNP

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence, supporting the development and commercialization of medical treatments to improve patient outcomes worldwide. Learn more at IQVIA's website.

Employment Type: Full-Time

Experience: 3 years

Vacancy: 1

Location: Milan, Lombardy, Italy

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