Global Regulatory Affairs Specialist

JR Italy; Pavia; 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 its dynamic team. This role involves leveraging regulatory expertise to shape global strategies and ensure compliance with health authority requirements. The ideal candidate will have a solid background in regulatory affairs, with experience in clinical drug development and lifecycle management. This is a unique opportunity to work in a multicultural environment and contribute to impactful projects in the pharmaceutical sector. If you are passionate about regulatory affairs and thrive in a fast-paced setting, this role is perfect for you.

Servizi

Competitive salary package

Permanent contract

Chemical contract

Competenze

• 3+ years of experience in Regulatory Affairs.
• Strong understanding of clinical drug development and lifecycle management.

Mansioni

• Serve as a regional regulatory lead and contact point with Health Authorities.
• Lead regulatory submissions, including NDAs and MAAs.

Conoscenze

Regulatory Affairs

Clinical Drug Development

Project Management

Stress Management

Strategic Thinking

Strumenti

Veeva Vault

Descrizione del lavoro

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 staff. IQVIA is recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international environment.

Purpose:

This role involves leveraging regulatory expertise to contribute to the development and execution of global regulatory strategies across regions, supporting business objectives, and ensuring alignment of product labeling and lifecycle management.

Main Responsibilities:

• Serve as a regional regulatory lead and contact point with Health Authorities.
• Develop and implement health authority interaction strategies and engagement plans.
• Lead regulatory submissions, including NDAs, MAAs, and variations, ensuring timely delivery and collaboration within the global team.
• Maintain accurate communication and tracking with health authorities.
• Support operational and compliance activities, including inspections and updates at GRT meetings.

Experience Required:

Approximately 3 years in Regulatory Affairs.

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 manage multiple projects and work in multicultural environments.

Soft Skills:

• Stress and time management.
• Planning, organizational, and strategic thinking skills.

We Offer:

• Competitive salary package
• Permanent contract
• Chemical contract

Note: EU work permit is required. Applications must meet the specified requirements; otherwise, they will not be fully considered. Consent for data processing according to GDPR is required. The position is open to candidates of all genders.