Regulatory Affairs TA and International Team Lead - 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 currently looking for an experienced Regulatory Affairs TA and International Team Lead who leads key activities of the TA and International team. You are responsible for the definition and implementation of regulatory strategies based on the good knowledge and appropriate interpretation of guidelines and directives. Based in Geneva, you report to the Head of Regulatory Affairs OM Pharma and your responsibilities include:

  • Lead the TA and International team (5 direct reports and up to 8 team members)
  • Contribute to the definition and the implementation of regulatory strategies to support/maintain registrations and coordinate operational activities of the team
  • Coordinate life cycle activities / maintenance of existing prodiuct licenses
  • Coordinate dossiers submission accodinng to the defined timelines (renewals, variations, responses to HA questions
  • Ensure compliance of the portfolio with legal requirements
  • Conduct risk assessments and set-up mitigation plans
  • Cooperate with internal stakeholders (marketing, Commercial, Global Drug Safety…) to ensure alignment on strategies
  • Be responsible for the management and development of staff by overseeing recruitment and training, evaluating performance, defining and assigning responsibilities, providing opportunities for career development
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:
  • Degree in Life Sciences, Pharmaceutical Sciences or Medical
  • 8 to 10 years of experience in Regulatory Affairs
  • Ability to perform comprehensive gap assessments and build effective regulatory strategies (Good knowledge and appropriate interpretation of guidelines, directives etc…)
  • Self-assertion, creative and solution-oriented work approach
  • Accuracy, flexibility, open minded, team spirit, organised, autonomous
  • Strategic thinking and acting, entrepreneurship skills
  • Experience in people management and development
  • Excellent communication and negotiation skills at all levels, diplomacy and respectful behavior
  • Discretion in the handling of confidential information
  • Good command of French and English both in written and oral conversation 

You are a mature regulatory professional and describe yourself as a solution oriented and flexible person able to influence internal and external stakeholders. Your work is characterized by its accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines. These skills will ensure your success in this role.

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