REGULATORY AFFAIRS MANAGER INFECTIOUS DISEASE/OTX - Geneva

Ort: Switzerland - Meyrin/Geneva

Funktion: Regulatory Affairs

Firma: OM Pharma

Marilda Martins

Regional Talent Acquisition Specialist

+41 58 851 67 69

Richtlinien für Agenturen

Ihr Profil

We are currently looking for a Regulatory Affairs Manager for our OM Pharma site in Geneva to coordinate regulatory affairs activities for the products under responsibility; mainly for the region of Switzerland and EU. You will report directly to the Regulatory Affairs Team Lead Infectious Disease /OTX and your responsibilities will include, but are not be limited to:

  • Manage successful submissions for new marketing authorisations, renewals, variations and line extensions for the following regions: EU, Switzerland and US
  • Ensure that changes are documented in accordance with internal procedures and are communicated in a timely manner to the Health Authorities
  • Responsibility for the designated regulatory projects with respective deadlines and forecasted budget, from regulatory assessment to strategy implementation
  • Collaboration with the CMC, Regulatory International and Regulatory groups to ensure appropriate planning and timely execution of the regulatory activities
  • Coordinate the responses to Q&A and ensure they are handled in a timely manner and in line with the approved product strategy
  • Ensure compliance of dossiers with legislation and with the general requirements in EU and CH
  • Coordinate the maintenance of up-to-date Modules 4, 5 and SmPC/PIL documentation according to international guidelines for products under responsibility
  • Support regarding preparation and handling of Aggregate Safety Reports (PBRER, RMP…) according to internal procedures for products under responsibilities
  • Represent regulatory affairs in relevant Project Teams (e.g. CMRST)
  • Interact/entry contact point with Regulatory authorities, partners and consultants
  • Interface with other departments on a national and international level
  • 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)
  • Min. 7 years experience in Regulatory in Europe and Switzerland within a pharmaceutical company (experience in US would be an asset)
  • Good knowledge and appropriate interpretation of guidelines, directives etc.
  • Fluent in English, French (German would be an asset)
  • Strategic thinking and acting, strong analytical and entrepreneurship skills
  • Self-assertion, creative, solution-oriented work approach
  • Accuracy, flexibility, open minded, team spirit, organised, autonomous
  • Strong adaptability and excellent communication and negotiation skills
  • Demonstrated ability to manage and lead projects successfully, interacting with senior stakeholders from different departments

You describe yourself as a solution oriented and flexible person who enjoys working in an intercultural environment. Your work is characterized by it’s accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines.

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

Inhalt ein-/ausblenden

Bewerben
Teilen
LinkedIn Xing Send to a friend

Richtlinien für Agenturen