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
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Head of Regulatory Science & Pharmacovigilance – DACH & HU in Wien Arbeitgeber: Angelini Pharma
Als Arbeitgeber im Gesundheitswesen bieten wir Ihnen die Möglichkeit, in einem dynamischen und unterstützenden Umfeld zu arbeiten, das auf Teamarbeit und Innovation setzt. Unsere Mitarbeiter profitieren von attraktiven Vergütungen, flexiblen Arbeitszeiten und umfangreichen Weiterbildungsmöglichkeiten, um ihre Karriere voranzutreiben. In der Region Niederösterreich, Oberösterreich, Wien und Burgenland genießen Sie nicht nur eine abwechslungsreiche Tätigkeit, sondern auch die Chance, einen positiven Einfluss auf die Gesundheitsversorgung unserer Kunden zu haben.
