Head of Regulatory Affairs (f/m)

Working area

Senior managers
   Other department managers
        Other department managers

JOB DESCRIPTION:

AOP Orphan erforscht, entwickelt, produziert und vertreibt innovative Medikamente und Verwaltungsmethoden für seltene Krankheiten - und ist ein europäischer Pionier auf dem Gebiet der seltenen Krankheiten. Der Schwerpunkt liegt in den Bereichen Hämatologie und Onkologie, Kardiologie und Pneumologie, Neurologie und Psychiatrie, Stoffwechsel- / genetische Störungen und Gastroenterologie. Im Rahmen einer Vorauswahl suchen wir für die Firma 1 Head of Regulatory Affairs (f/m) In this central role you are overseeing and ensuring the implementation of all AOP regulatory activities including registration of new products and life-cycle management of existing products (both AOP and in- licensed). Responsibilities in detail: Overview of all AOP Regulatory Affairs (RA) activities worldwide (AOP products and in-licensed products) Responsible for the RA Department consisting of two groups, in total 8-10 co-workers. Providing leadership, guidance and mentoring to these groups Lead RA Department & RA personnel ensuring project deliverables according to R&D goals Act as team player within peer group (heads) and within project teams Personal in-depth responsibility within selected projects assigned by Director R&D Responsibility for the RA Budget Evaluation and refinement of pathway to licensure together with Development RA and Director R&D Interaction and tight cooperation with competent authorities including EMA, US-FDA and National Authorities Evaluation and prioritization of life-cycle-management activities with LCM RA and Director R&D Tight cooperation with partner companies concerning in-licensed products Maintain knowledge of and appropriately implement relevant regulations Proactive approach to RA issues of relevance for AOP Professional skills: Sound scientific background, preferable Doctoral degree in the life- or bio-medical scienc many years industry experience in Regulatory Affairs (preferably Orphan diseases) Experience working in cross-functional project teams within a matrix-organization Experience in Leadership and Budget responsibility Sound knowledge of relevant regulations, excellent analytical skills as applied to medical, scientific and technical information Excellent verbal and written communication skills in English and German Excellent presentation skills Strong IT skills including proficiency and experience with MS Office (experience with eSubmission tools, e.g. DocuBridge preferred) A very versatile job with a high degree of independence and responsibility in a successful international team awaits you. The gross monthly salary provided for this function is a minimum of € 5.000,- based on full-time employment. Any potential overpayment depends on professional experience and qualifications. Wenn Sie Interesse an dieser Position haben, senden Sie bitte Ihre aussagekräftige Bewerbung im Rahmen einer Vorauswahl per mail an: richard.hartmann@ams.at Geben Sie bitte bei der Bewerbung die Auftragsnummer (ADG Nr. ) an Das Mindestentgelt für die Stelle als Head of Regulatory Affairs (f/m) beträgt 5.000,00 EUR brutto pro Monat auf Basis Vollzeitbeschäftigung. Bereitschaft zur Überzahlung.

Work hours:

• Without entering work hours
  

Requirements

source: https://www.ec.europa.eu/eures

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