REGULATORY AFFAIRS MANAGER Infectious Disease/OTX CDD 9 months - Geneva

Ort: Switzerland - Meyrin/Geneva

Funktion: Regulatory Affairs

Firma: OM Pharma

Marilda Martins

International Talent Acquisition Specialist

+41 58 851 67 69

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Ihr Profil

We are looking for a Regulatory Affairs Manager starting from October2018  for our OM Pharma site in Geneva to support regulatory affairs activities of the OM pharma portfolio. Your main responsabilities are the following:
  • Manage successful submissions for new marketing authorisations, renewals, variations and line extensions for various regions worldwide .Coordinate the responses to Q&A and ensure they are handled in a timely manner and in line with the approved product strategy
  • Responsibility for the designated regulatory projects with respective deadlines and forecasted budget, from regulatory assessment to strategy implementation
  • Collaboration with the CMC, International and submission groups to ensure appropriate planning and timely execution of the regulatory activities
  • Ensure compliance of dossiers with legislation and with the general requirements in respective regions
  • Support regarding preparation and handling of Aggregate Safety Reports (PBRER, RMP…) according to internal procedures
  • Interact with Regulatory authorities, partners and consultants
  • Interface with other departments on a national and international level
  • Ensure that changes are documented in accordance with internal procedures and are communicated in a timely manner to the Health Authorities
  • Ensure tracking tools and regulatory databases are maintained up to date
We are looking for a customer- and service-oriented person who brings experience in working with a wide variety of stakeholders across diverse teams both internally and with external partner companies. Furthermore, your profile meets the following criteria:
  • Scientific or Medical degree (pharmacy, chemistry or, biochemistry)
  • At least 5 years’ experience in Regulatory Affairs worldwide in within a pharmaceutical company
  • Fluent in English and French both written and spoken
  • Strategic thinking and acting, strong analytical and entrepreneurship skills
You describe yourself as a solution oriented and flexible person who enjoys working in an intercultural environment. Your work is characterized by its accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines. Thanks to you strong communication and negotiation skills, you are able to lead projects successfully and to interact with senior stakeholders from different departments.

Über uns

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist. Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen. Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Für mehr Informationen gehen Sie bitte auf: http://www.viforpharma.com/de/über-vifor-pharma/wer-wir-sind

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