REGULATORY AFFAIRS CMC MANAGER Infectious Disease / OTX - Geneva

Lieu: Switzerland - Meyrin/Geneva

Fonction: Regulatory Affairs

Compagnie: OM Pharma

Marilda Martins

International Talent Acquisition Specialist

+41 58 851 67 69

Conditions pour les agences de placement

Votre 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.

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.

Pour plus d’informations, veuillez consulter notre site: http://www.viforpharma.com/fr/a-propos-de-vifor-pharma/qui-sommes-nous.

Afficher/masquer le contenu

Postuler
Partager
LinkedIn Xing Send to a friend

Conditions pour les agences de placement