Regulatory Affairs Specialist International 100% - Geneva

OM Pharma — Geneve
04.07. | Employee | 100%

Regulatory Affairs Specialist International 100% - Geneva

We are currently looking for an  Regulatory Affairs Specialist International  to join our team. Based in Meyrin/Geneva, you report to the Regulatory affairs International Team Lead and your responsibilities include the following tasks:

  • Manage successful submissions for new marketing authorisations, renewals, variations and line extensions for International regions (LATAM, MEA, APAC, CIS) and drive the approval process
  • Coordinate responses to Q&A for projects under responsibility and ensure they are handled in a timely manner 
  • Responsibility for the designated regulatory projects with respective deadlines and forecasted budget, from regulatory assessment to implementation
  • Collaboration with the EU/CH/US and Regulatory Excellence groups to ensure appropriate planning and timely execution of the regulatory activities
  • Ensure compliance of dossiers with legislation and with the general requirements in respective regions
  • Ensure that changes are documented in accordance with internal procedures and are communicated in a timely manner to the Health Authorities
  • Ensure tracking tools and regulatory databases are maintained up to date according to internal guidelines

For this role, 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 bringing the following profile :

  • University degree in Scientific area

  • At least 2 years of work experience in Regulatory Affairs in the International markets (LATAM, MEA, APAC, CIS) in the pharmaceutical industry

  • Excellent communication and negotiation skills 

  • Fluent in English and French both in oral and written conversation

You can navigate organizational complexity through teamwork, clearly structured data enquiries and effective communication. You are 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.

04.07.2020
Employee, 100%

Contact

OM Pharma

Brice Muller

Phone: '+41 58 851 81 24

Fax: +41 58 851 80 03


Vifor Pharma

Flughofstrasse 61Glattbrugg

Industry

Biotechnology / Chemistry / Pharmaceutical

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