Head of Regulatory Science & Pharmacovigilance – 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

At Angelini Pharma, we believe every product we bring to patients starts with doing things right: with rigor, with passion, and with people in mind.

We’re looking for a regulatory leader to guide our Regulatory Science and Pharmacovigilance activities across Germany, Austria, Switzerland and Hungary.

About the role

You’ll be accountable for local Regulatory activities ensuring compliance with Angelini global/local procedures and with national and international law/regulations for the products (pharma and non-pharma) registered and distributed in the DACH & HU cluster; provide regulatory strategic input to support commercial success of the Country Organizations by increasing and maintaining products portfolio; build and maintain strategic interactions with the Local Health Authorities to obtain the relevant approvals for regulatory applications (i.e., new MAAs, MA variations, MA renewals, certifications etc.); ensure interaction and alignment with the Global RS team to support relevant priorities and objectives; and lead the local Patient Safety Organization , which functionally reports to the EU QPPV, and oversee the local pharmacovigilance activities.

Responsibilities

• Ensure leadership to the cluster and direct the team close to the business needs and focused on patient centricity
• Define regulatory strategy, planning, submission, implementation, and information management for the Local portfolio in the cluster, in coordination with Regulatory Science Region Europe.
• Support the Global Regulatory Science organisation to build-up efficient regulatory strategy for Global portfolio in the cluster
• Execute the regulatory activities (new authorisations and maintenance activities) in line with the priorities and timeline defined by Global Regulatory Science for Global portfolio in the cluster
• Manage the regulatory and business environment to maximize market potential.
• Support local business through Regulatory input to the Country Managers, to the relevant Country organizations.
• Foster, coordinate and create valuable synergies in the cluster to maximize excellence of regulatory and patient safety resources and cross-countries opportunities
• Build and maintain proficient relationship with National Regulatory Authorities to navigate properly a complex regulatory environment
• Build and maintain relationship with Relevant Associations in the Countries creating valuable networks
• Monitor the regulatory environment in the countries securing competitive intelligence on main competitors, exchanging key and strategic information.
• Ensure compliance to the applicable local law for the registered and marketed products.
• Ensure that the systems of internal management for regulatory and Patient Safety activities (RIMS, artwork management, advertisement, etc.) are properly oversees and maintained up to allow a precise and correct tracking of data for the products in the cluster.
• Ensure the compliance with relevant local Regulatory and Patient Safety SOPs and Working Instructions in the cluster.
• Ensure that all promotional materials are reviewed/approved in line with Global and Local SOPs and with local applicable rules/regulations.

Requirements

• University Degree with a strong scientific background
• At least 7-10 years of experience in Regulatory Affairs
• At least 1-2 years of people management experience is required, including the leadership of small teams.
• Fluent English and German are required; Italian is a plus.
• You bring strong leadership and excellent communication, interpersonal and presentation skills, combined with analytical, innovative and critical thinking.

The salary for this role starts from €110,000 gross per year, depending on experience and location. The offer is determined based on gender-neutral criteria, including relevant skills, competencies, and experience.

Angelini Pharma is an equal Opportunity Employer. We believe that diversity is a huge value that contributes to individual and company success. We are committed to create a diverse and inclusive environment