Global Regulatory Affairs Specialist

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

Descrizione del lavoro

An established industry player is seeking a Global Regulatory Affairs Specialist to join their dynamic team in Treviso. This role focuses on leveraging regulatory expertise to shape EU and global strategies, ensuring compliance with labeling and regulatory standards. The ideal candidate will have a solid background in regulatory affairs, particularly within the pharmaceutical sector, and will thrive in a multicultural environment. This position offers a permanent contract and a competitive salary package, making it an exciting opportunity for professionals looking to advance their careers in a leading pharmaceutical company.

Servizi

Competitive salary package

Permanent contract

Chemical contract

Competenze

• 3+ years of experience in Regulatory Affairs.
• Strong understanding of EU and global regulatory strategies.

Mansioni

• Lead regulatory interactions with health authorities.
• Manage submissions and ensure compliance with regulations.

Conoscenze

Regulatory Affairs

Clinical Development

Biologics Knowledge

Project Management

Multicultural Sensitivity

Strumenti

Veeva Vault

Descrizione del lavoro

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Global Regulatory Affairs Specialist, Treviso

Job Details:

Client:

Location:

Job Category:

Other

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EU work permit required:

Yes

Job Reference:

8160257735766573056337115

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 biotech industry, is seeking a Global Regulatory Affairs Specialist to join their dynamic, international team through IQVIA.

Purpose:

The role involves leveraging regulatory expertise to define and execute EU, extra-EU, and global strategies, supporting development and lifecycle management of products, and ensuring alignment with core labeling and global regulatory standards.

Main Responsibilities:

• Serve as regional/local regulatory lead and liaise with Health Authorities.
• Contribute to global health authority interaction strategies.
• Develop and implement health authority engagement plans, including meetings.
• Manage communication and tracking with relevant health authorities.
• Lead regulatory sub-teams to ensure timely filings and collaboration on dossier development.
• Align submission timelines 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 GVP inspections.
• Update project and submission statuses in meetings.
• Support interactions with affiliates, IMDD, and partners.

Experience Required:

Approximately 3 years in Regulatory Affairs.

Skills & Qualifications:

• 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/multinational environments.

Soft Skills:

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

What We Offer:

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

IQVIA reserves the right to evaluate candidates based on domicile, residence, and relevant experience. Applications without the required qualifications will not be fully considered. Please provide consent for data processing as per GDPR regulations. This urgent search is open to candidates of all genders (L.903/77).