Global Rare Disease Regulatory Affairs Specialist - EU & Intl

IQVIA Italia; Parma; In loco; EUR 41.000 - 51.000; Tempo pieno

Vantaggi offerti da questo lavoro

Private health insurance

Pension fund

5% bonus/MBO

Descrizione del lavoro

Chiesi Farmaceutici, in collaboration with IQVIA, seeks a Global Rare Disease Regulatory Affairs Specialist EU/INT to join a dynamic, international team.

Under supervision, you will prepare regulatory documents for submissions, coordinate lifecycle management, and liaise with partners to ensure timely responses.

The role offers a competitive salary, 5% bonus, private health insurance and a defined career path within a multinational environment.

Competenze

• 2-3 years experience in regulatory affairs in EU or INT.
• Experience in lifecycle management of regulatory filing.
• Ability to prepare high-quality submissions under supervision.
• Strong attention to detail and document quality.
• Well-developed written and oral communication skills.
• Strong time management and ability to manage complex tasks.
• Ability to work independently or in a team.
• English level from advanced to fluency.

Mansioni

• Prepare and maintain regulatory documents for submissions to regional authorities within timelines.
• Plan, coordinate and manage regulatory submissions to regional agencies across product lifecycles.
• Review submission documents and provide recommendations for improvement.
• Provide regulatory guidance to colleagues from other functions.
• Prepare responses to questions from regulatory agencies within timeframes.
• Liaise with internal and external stakeholders to obtain data for submissions.
• Use data management systems to track regulatory information.

Conoscenze

Regulatory affairs experience

Attention to detail

Time management

Written and oral communication

Team player

Independent work

English proficiency

Descrizione del lavoro

Chiesi Farmaceutici, in collaboration with IQVIA, seeks a Global Rare Disease Regulatory Affairs Specialist EU/INT to join a dynamic, international team.

Under supervision, you will prepare regulatory documents for submissions, coordinate lifecycle management, and liaise with partners to ensure timely responses.

The role offers a competitive salary, 5% bonus, private health insurance and a defined career path within a multinational environment.