Regional Head of Regulatory Science & PV - DACH & HU

Angelini Pharma; Wien; On-site; EUR 99,000 - 121,000; Full time

Job summary

Angelini Pharma seeks a Regulatory Leader to guide Regulatory Science and Pharmacovigilance across Germany, Austria, Switzerland and Hungary. You will ensure compliance with local and international regulations while supporting commercial success of the Country Organizations.

You will define regulatory strategy, lead the local Patient Safety Organization, and oversee pharmacovigilance, building strong relationships with national authorities to secure timely approvals for MA variations and new

Qualifications

• University degree in a scientific field.
• 7–10 years of regulatory affairs experience.
• 1–2 years of people management experience.
• Fluent English and German; Italian is a plus.

Responsibilities

• Define regulatory strategy, planning, submission, implementation, and information management for the Local portfolio in the cluster, in coordination with Regulatory Science Region Europe.
• Lead the local Patient Safety Organization, overseeing pharmacovigilance activities.
• Build and maintain relationships with National Regulatory Authorities and relevant associations.
• Ensure compliance with local laws for registered and marketed products.
• Coordinate alignment with Global Regulatory Science and support global portfolio priorities.
• Provide regulatory input to Country Managers and relevant Country organizations.
• Ensure systems (RIMS, artwork management, advertising) are maintained for data tracking.
• Monitor regulatory environment to gather competitive intelligence and opportunities.

Skills

Regulatory affairs experience

People management

English

German

Italian

Education

University degree in scientific field

Job description

Angelini Pharma seeks a Regulatory Leader to guide Regulatory Science and Pharmacovigilance across Germany, Austria, Switzerland and Hungary. You will ensure compliance with local and international regulations while supporting commercial success of the Country Organizations.

You will define regulatory strategy, lead the local Patient Safety Organization, and oversee pharmacovigilance, building strong relationships with national authorities to secure timely approvals for MA variations and new