Global Regulatory Affairs Specialist

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

Descrizione del lavoro

An established industry player in the pharmaceutical sector is seeking a Global Regulatory Affairs Specialist to join their dynamic team in Monza. This role involves leading regulatory strategies, managing health authority interactions, and ensuring compliance across various projects. The ideal candidate will have a strong background in Regulatory Affairs, with approximately three years of experience and familiarity with electronic document management systems. This position offers a competitive salary and a permanent contract, making it an exciting opportunity for professionals looking to advance their careers in a multicultural environment.

Servizi

Competitive salary

Permanent contract

Chemical contract

Competenze

• Approximately 3 years in Regulatory Affairs.
• Experience with electronic document management systems.

Mansioni

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

Conoscenze

Regulatory Affairs

Clinical Development

Project Management

Strategic Thinking

Formazione

Bachelor's Degree in Life Sciences

Strumenti

Veeva Vault

Descrizione del lavoro

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Global Regulatory Affairs Specialist, Monza

Client:

Location:

Job Category: Other

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EU work permit required: Yes

Job Reference:

8160257735766573056337119

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 seeking a Global Regulatory Affairs Specialist to join their team in a dynamic, international environment.

Purpose:

The specialist will be a core member of the GRT, supporting the development and execution of global regulatory strategies across regions to ensure business objectives are met.

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.
• Ensure accurate communication and tracking with relevant health authorities.
• Lead regulatory sub-teams for filings and collaborate with GRT members.
• Align regulatory submission timelines with project and company goals.
• Review and contribute to regulated documents.
• Support operational and compliance activities, including inspections.
• Provide updates on project statuses at GRT meetings.
• Support interactions with affiliates, IMDD, and partners.

Experience Required:

Approximately 3 years in Regulatory Affairs.

Technical Skills:

• Understanding of clinical 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 environments.

Soft Skills:

• Stress and time management.
• Planning and organizational skills.
• Strategic thinking.

We offer:

• Competitive salary.
• Permanent contract.
• Chemical contract.

IQVIA reserves the right to evaluate candidates based on domicile, residence, work experience, and studies. Applications lacking these requirements will not be fully considered. Please authorize the processing of personal data according to GDPR regulations. This urgent research is open to candidates of all genders (L.903/77).