Global Regulatory Affairs Specialist

JR Italy; Varese; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An exciting opportunity awaits a Global Regulatory Affairs Specialist in a dynamic and international environment. This role involves leveraging regulatory expertise to define and execute global strategies, ensuring alignment with product labeling and lifecycle management. You will lead regulatory sub-teams, manage health authority interactions, and support compliance activities, all while working in a collaborative setting. Join a forward-thinking company that values strategic thinking and offers a competitive salary package along with a permanent contract. If you thrive in multicultural environments and have a passion for regulatory affairs, this position is perfect for you.

Servizi

Competitive salary package

Permanent contract

Chemical contract

Competenze

• Approximately 3 years of experience in Regulatory Affairs.
• Understanding of clinical development and biologics products.

Mansioni

• Serve as a regulatory lead and point of contact with health authorities.
• Develop and manage health authority engagement plans.

Conoscenze

Regulatory Affairs

Clinical Development

Stress Management

Time Management

Strategic Thinking

Formazione

Bachelor's Degree in Life Sciences

Strumenti

Veeva Vault

Descrizione del lavoro

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Global Regulatory Affairs Specialist, Varese

Client:

Location:

Job Category: Other

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EU work permit required: Yes

Job Reference:

8160257735766573056337121

Job Views:

1

Posted:

08.05.2025

Job Description:

Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies worldwide, with over 80 years of experience in the pharmaceutical and biotech industry – is expanding its team. IQVIA is recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international environment.

Purpose:

As a core member of the GRT and strategic partner of the GRL, leverage regulatory expertise to contribute to defining and executing aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. Support the development and execution of global regulatory strategies for the TPP, ensuring alignment 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 health authority interaction strategies in collaboration with GRT.
• Develop and manage health authority engagement and interaction plans, including authoring and leading meetings.
• Maintain accurate communication and tracking with relevant health authorities.
• Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop global dossiers, and collaborate with GRT members.
• Ensure regulatory submission timelines align with program and company goals.
• Review and contribute to regulated documents.
• Support operational and compliance activities, including health authority contact reports (EU & EXTRA-EU).
• Assist with GMP, GCP, and GPV inspections.
• Provide updates on project and submission status at GRT meetings.
• Support updates to affiliates and interactions with IMDD and partners.

Experience Required:

Approximately 3 years of experience in Regulatory Affairs.

Education:

Languages:

Technical Skills:

• Understanding of clinical development and biologics products.
• 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 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 requirements. Applications lacking these requirements will not be fully considered. Please authorize the processing of personal data (DL196/2003) under GDPR. This research is urgent and open to candidates of all genders (L.903/77).