Regulatory Affairs TA and International Team Lead - Geneva

Lieu: Switzerland - Meyrin/Geneva

Fonction: Regulatory Affairs

Compagnie: OM Pharma

Marilda Martins

International Talent Acquisition Specialist

+41 58 851 67 69

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Votre 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.

A propos de nous

Le Groupe Vifor Pharma, anciennement Groupe Galenica, est une entreprise Specialty Pharma mondiale qui se consacre à la recherche, au développement, à la fabrication et à la commercialisation de ses propres produits pharmaceutiques. Il est le partenaire de choix pour les solutions innovantes axées sur le patient. L’entreprise, qui entend devenir le leader mondial des traitements de la carence en fer et des affections néphrologiques et cardio-rénales, aspire à aider les patients du monde entier souffrant de maladies graves et chroniques à mener une vie meilleure et plus saine. Le Groupe Vifor Pharma possède des sites de production en Suisse et au Portugal, ainsi qu’un réseau dynamique de sociétés affiliées et de partenaires lui assurant une vaste couverture de marché dans le monde entier. L’entreprise affiche une présence mondiale en constante augmentation mais conserve de solides racines dans son marché d’origine, la Suisse.

Le Groupe Vifor Pharma est constitué de Vifor Pharma, de Vifor Fresenius Medical Care Renal Pharma – sa société commune avec Fresenius Medical Care –, de Relypsa et d’OM Pharma.

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Conditions pour les agences de placement