Global Regulatory Affairs Lead (Maternity Cover)

IQVIA Italia; Parma; In loco; EUR 46.000 - 57.000; Tempo pieno

Descrizione del lavoro

IQVIA on behalf of Chiesi Farmaceutici seeks a Global Regulatory Affairs Manager to join our international team for a fixed-term maternity cover. Based in Italy, you will partner with GRL and GRT to shape regulatory strategies across EU and global markets.

The role requires 3–4 years in international regulatory affairs, with preferred experience in rare diseases. You will shepherd HA interactions, author regulatory documents, and ensure timely submissions while maintaining compliance.

Competenze

• 3–4 years' experience in International Regulatory Affairs.
• Experience in regulatory affairs within rare diseases is preferred.
• Proficient in regulatory submissions and lifecycle management.

Mansioni

• Serve as regional/local regulatory lead and HA contact.
• Contribute (independently or with GRL guidance) to global HA interaction strategy.
• Develop and manage health authority engagement plans for assigned products incl. authoring meetings.
• Communicate/track interactions with HAs for projects in remit.
• Lead regulatory sub-team to meet NDA/MAA/Extensions/Variations timelines and develop core global dossier.
• Ensure regulatory submission timelines align with program objectives.
• Contribute to content and reviews for regulated documents.
• Support GMP, GCP, and GPV inspections from health authorities.
• Provide updates on project and submissions status at GRT meetings.
• Support GRL on updates to Affiliates and interactions with IMDD and partners.

Conoscenze

International Regulatory Affairs

Regulatory strategy

HA interaction

Veeva Vault

Strumenti

Veeva Vault

Descrizione del lavoro

IQVIA on behalf of Chiesi Farmaceutici seeks a Global Regulatory Affairs Manager to join our international team for a fixed-term maternity cover. Based in Italy, you will partner with GRL and GRT to shape regulatory strategies across EU and global markets.

The role requires 3–4 years in international regulatory affairs, with preferred experience in rare diseases. You will shepherd HA interactions, author regulatory documents, and ensure timely submissions while maintaining compliance.