Trainees in Regulatory Affairs 100% - Geneva

OM Pharma — Geneve
04.02.2020 | Employee | 100%

Trainees in Regulatory Affairs 100% - Geneva

We are currently looking for two Regulatory Affairs Trainees for our OM Pharma site in Geneva for a period of 6 to 8 months to provide Regulatory Affairs Department with support in various life cycle management activities and direct management of assigned projects. Your main responsibilities :

  • Manage successful submissions for renewals and variations (CMC and labelling) for various regions worldwide
  • Coordinate the responses to Q&A and ensure they are handled in a timely manner and in line with the approved product strategy
  • Responsibility for the designated regulatory projects with respective deadlines 
  • Collaboration with the CMC, Labelling, International, Submission and Operation 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
  • Interact with Regulatory partners and consultants
  • Ensure tracking tools and regulatory databases are maintained up to date

We are looking for a customer- and service-oriented person who is willing to work with a wide variety of stakeholders across diverse teams both internally and with external partner companies. Furthermore, your profile meets the following criterias:

  • Scientific/life sciences degree, Pharmacist or Master 1 or 2 in Regulatory Affairs or similar
  • Fluent in English and French both written and spoken
  • Good knowledge of MS-Office tools
  • Excellent communication skill

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.

04.02.2020
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

Vifor Pharma

Flughofstrasse 61Glattbrugg

Industry

Biotechnology / Chemistry / Pharmaceutical
Salary

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