19 days ago

REGULATORY AFFAIRS MANAGER INFECTIOUS DISEASE/OTX - Meyrin/Geneva

OM Pharma

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REGULATORY AFFAIRS MANAGER INFECTIOUS DISEASE/OTX - Meyrin/Geneva

We are currently looking for a Regulatory Affairs Manager for our OM Pharma site in Geneva to coordinate regulatory affairs activities for the products under responsibility; mainly for the region of Switzerland and EU. You will report directly to the Regulatory Affairs Team Lead Infectious Disease /OTX and your responsibilities will include, but are 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
  • Responsibility for the designated regulatory projects with respective deadlines and forecasted budget, from regulatory assessment to strategy implementation
  • Collaboration with the CMC, Regulatory International and Regulatory groups to ensure appropriate planning and timely execution of the regulatory activities
  • 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 (PBRER, RMP...) according to internal procedures for products under responsibilities
  • Represent regulatory affairs in relevant Project Teams (e.g. CMRST)
  • Interact/entry contact point with Regulatory authorities, partners and consultants
  • Interface with other departments on a national and international level
  • Ensure tracking tools and regulatory databases are maintained up to date

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. 7 years experience in Regulatory in Europe and Switzerland within a pharmaceutical company (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
  • Demonstrated ability to manage and lead projects successfully, interacting with senior stakeholders from different departments

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.

Sarah Osswald
International Talent Acquisition Specialist
+41 58 851 83 24