Regulatory Affairs Team Lead - Geneva

Lieu: Switzerland - Meyrin/Geneva

Fonction: Regulatory Affairs

Compagnie: OM Pharma

Niveau de Séniorité: Senior Manager

Ana Napolitano

Talent Acquisition Consultant

+41 58 851 62 10

Conditions pour les agences de placement

Votre 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. The ideal candidate brings the following skills and experience:
  • University Degree (PhD / MSc) in Life Sciences, Pharmaceutical Sciences or Medical 
  • 8 years of experience in Regulatory Affairs, within the 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 behaviour
  • Regulatory Affairs experience in the US is beneficial
  • Fluency language skills in English, language skills in French are preferable
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 characterised 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.

A propos de nous

OM Pharma est une entreprise mondiale de biotechnologie basée à Genève. OM Pharma est aujourd’hui un leader dans la prévention des infections respiratoires et urinaires récurrentes et est également ac¬tive dans le traitement des maladies vasculaires. Elle œuvre dans le monde entier grâce à un sol¬ide réseau de partenaires internationaux et continue à investir dans la R&D pour développer des produits immunothérapeutiques dérivés des microbes, destinés à traiter les troubles immunitaires aigus et chroniques résultant d’infections et d’inflammations.
OM Pharma s’efforce d’améliorer la qualité de vie des patients dans le monde entier en leur donnant accès à une meilleure prise en charge des maladies infectieuses et des déséquilibres immunitaires en gérant l’ensemble du cycle de vie du portefeuille, de la R&D à la production.

Pour plus d’information, visitez notre site: ompharma.com.

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Conditions pour les agences de placement