9 days ago

REGULATORY AFFAIRS MANAGER Infectious Disease / OTX - Geneva

OM Pharma

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REGULATORY AFFAIRS MANAGER Infectious Disease / OTX - Geneva

We are looking for a Regulatory Affairs Manager for our OM Pharma site in Geneva to coordinate regulatory affairs activities for mainly Switzerland and EU region for products under responsibility. You will report to the Regulatory Affairs Team Lead Infectious Disease /OTX and your responsibilities will include, but not be limited to:
  • Manage successful submissions for new marketing authorisations, renewals, variations and line extensions for the following regions: EU, Switzerland and US
  • Ensure that changes are documented in accordance with internal procedures and are communicated in a timely manner to the Health Authorities
  • Collaboration with the Regulatory Affairs CMC, International and Regulatory Operations & Clinical Support groups to ensure appropriate planning and submissions to Health Authorities
  • Coordinate the responses to Q&A and ensure they are handled in a timely manner and in line with the approved product strategy
  • Ensure compliance of dossiers with legislation and with the general requirements in EU and CH
  • Coordinate the maintenance of up-to-date Modules 4, 5 and SmPC/PIL documentation according to international guidelines for products under responsibility
  • Support regarding preparation and handling of Aggregate Safety Reports  (PSURs, RMP...) according to internal procedures for products under responsibilities
  • Responsibility for the designated regulatory projects with respective deadlines and within the defined budget, from regulatory assessment to strategy implementation
  • Interface with other departments on a national and international level
  • Interact/entry contact point with Regulatory authorities, partners and consultants

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 or Medical degree (pharmacy, chemistry or, biochemistry)
  • Min. 5 years experience in Regulatory in Europe and Switzerland (experience in US would be an asset)
  • Good knowledge and appropriate interpretation of guidelines, directives etc.
  • Fluent in English, French (German would be an asset)
  • Strategic thinking and acting, strong analytical and entrepreneurship skills
  • Self-assertion, creative, solution-oriented work approach
  • Accuracy, flexibility, open minded, team spirit, organised, autonomous
  • Strong adaptability and excellent communication and negotiation skills
You describe yourself as a solution oriented and flexible person who enjoys working in an intercultural environment. Your work is characterized by it's accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines.