Head of Regulatory Science & Pharmacovigilance – DACH & HU

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.

Ready to shape the future of patient care across the DACH & HU cluster? Apply now and grow with us.

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