Regulatory Affairs Teamlead - Geneva

Ort: Switzerland - Meyrin/Geneva

Funktion: Regulatory Affairs

Firma: OM Pharma

Senioritätslevel: Senior Manager

Ana Napolitano

Talent Acquisition Consultant

+41 58 851 62 10

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Ihr Profil

We are currently looking for an experienced Regulatory Affairs Team Lead who will lead key activities for EU, US and CH regions. You will be 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 will report to the Head of Regulatory Affairs OM Pharma and your responsibilities will include:
  • Contribute to the definition and the implementation of regulatory strategies to expand the business (geographic expansion, new indications…) and support/maintain registrations
  • Coordinate life cycle activities / maintenance of existing product licenses
  • Coordinate dossiers submission according 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 to ensure alignment on strategies
  • Lead the EU, US and CH regions team (2 direct reports): 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 :
  • University Degree (PhD / MSc) in Life Sciences, Pharmaceutical Sciences or Medical
  • 10 years of experience in Regulatory Affairs, with a proven experience on US market (new registrations) and EU region (support to clinical trials activities)
  • Experience in people management and development
  • 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
  • Strategic thinking and acting, entrepreneurship skills
  • Excellent communication and negotiation skills at all levels, diplomacy and respectful behavior
  • Good command of French and English oth in oral and written 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 you are able to work under pressure and to deal with tight deadlines. These skills will ensure your success in this role.

Über uns

Die Vifor Pharma Gruppe ist ein globales Spezialitäten-Pharmaunternehmen. Sie hat sich zum Ziel gesetzt, globale Marktführerin in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu werden. Das Unternehmen ist der bevorzugte Partner für Pharmaprodukte und innovative, patientenorientierte Lösungen. Die Vifor Pharma Gruppe will Patienten mit schweren und chronischen Krankheiten auf der ganzen Welt dabei helfen, ein Leben in besserer Gesundheit zu führen. Das Unternehmen entwickelt, produziert und vermarktet pharmazeutische Produkte für eine optimale Patientenversorgung. Die Vifor Pharma Gruppe nimmt in allen ihren Kerngeschäften eine führende Position ein und besteht aus folgenden Unternehmen: Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma (ein gemeinsam mit Fresenius Medical Care geführtes Unternehmen); und OM Pharma.

Die Vifor Pharma Gruppe hat ihren Hauptsitz in der Schweiz und ist an der Schweizer Börse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348) kotiert.

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