REGULATORY AFFAIRS CMC MANAGER Infectious Disease / OTX - Geneva

Ort: Switzerland - Meyrin/Geneva

Funktion: Regulatory Affairs

Firma: OM Pharma

Marilda Martins

International Talent Acquisition Specialist

+41 58 851 67 69

Richtlinien für Agenturen

Ihr Profil

We are looking for a Regulatory Affairs CMC Manager for our OM Pharma site in Geneva to coordinate CMC activities for products under responsibility. You will report to the Head of Regulatory Affairs Infectious Diseases and your responsibilities will include, but not be limited to:

  • Define and drive CMC regulatory strategy for ID/OTX projects (marketed products), conduct risk assessments and set-up mitigation plans
  • Identify required content to ensure compliance with regulatory standards and review CMC documents from technical departments
  • Author high-quality CMC documents in the frame of renewals, variations and life cycle management activities
  • Liaise with Therapeutic Areas, International, Submission and Regulatory Operations groups to ensure appropriate planning and timely preparation of CMC-related submissions
  • Manage answers to questions from Health Authorities related to CMC topics
  • Coordinate assessment of worldwide impact of proposed manufacturing changes, ensure the regulatory implications have been considered and provide regulatory strategy for optimal and timely implementation of these changes
  • Provide required support to audits/inspections from partners and Health Authorities
  • Represent Regulatory CMC in cross-functional project teams
  • Ensure alignment with Global CMC team and contribute to the improvement of departmental and cross-functional processes
  • Provide guidance and mentor junior staff
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 background
  • At least 7 years of work experience in Regulatory Affairs CMC, with proven expertise in Biologics
  • Good knowledge and appropriate interpretation of guidelines, directives etc
  • Experience in projects management : strategic thinking and acting, entrepreneurship skills
  • Leadership qualities, diplomacy and respectful behavior
  • Strong adaptability, excellent communication and negotiation skills
  • Fluent in English and French (good command of both, written and spoken language is mandatory)

You describe yourself as a solution oriented and flexible person who enjoys working in a dynamic 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.

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